Top Medical Device and Drug Recalls of 2024 Resulting in Lawsuits and Investigations

Recalls for BioZorb, Cartiva, Impella, Sterile Water and Oxbryta have each resulted in a growing number of lawsuits against manufacturers, for failing to warn about defects or potential side effects that have caused injuries.

Defective medical devices and undisclosed drug side effects can have serious consequences for individuals and their families, particularly when those risks outweigh benefits provided by the treatments, leading manufacturers or federal regulators to remove products from the market.

Throughout 2024, there were several major recalls impacting widely used medications and medical devices, which were found to pose an unreasonable risk of serious health complications. As a result, many manufacturers now face lawsuits brought by former users, seeking financial compensation for injuries and damages that could have been avoided if earlier warnings or recalls had been issued.

In this featured post, AboutLawsuits will highlight the most significant medical device and drug recalls of 2024, which have resulted in lawsuits or investigations by product liability lawyers. For each of these recall lawsuits, we have provided a timeline of events leading up to the recall, an outline of the risks associated with the medication or device, as well as an update on the status of the litigation.

For those impacted by these recalls, we will also discuss available resources and steps to consider if you or a loved one have experienced complications from a recalled product.

BioZorb Recalls Over Migration & Erosion Problems

A BioZorb tissue marker recall was issued in 2024, months after the manufacturer began facing lawsuits brought by former users left with devastating injuries when the device migrated or failed to dissolve in the body, often resulting in the need for surgical removal.

The BioZorb Marker is an implantable breast tissue marker developed by Hologic Inc., which was approved by the FDA in 2015. The markers are typically implanted at the tumor site in breast cancer patients undergoing radiation therapy, helping to precisely target any remaining cancer cells. By identifying the exact location, the implant ensures radiation is focused on the tumor bed while reducing exposure to surrounding healthy tissue.

The device is made up of a permanent titanium component and a temporary plastic component that is supposed to naturally dissolve over time. It is designed to be sterile and intended for single-use implantation.

However, Hologic first issued a Medical Device Safety Notification in March 2024, warning healthcare professionals to be aware of potential adverse events being reported by patients after receiving a BioZorb Marker, where the implant was failing to dissolve.

The FDA later announced the Class I BioZorb recall on May 22, after identifying at least 71 reports of injuries caused by the device, ranging from pain and infection to more complex complications like device movement and erosion. The agency warned that problems with the device have often resulted in the need for medical interventions to remove the implant.

The recall impacted approximately 53,492 BioZorb Markers, including model numbers F0405 , F0404, F0331, F0231, F0221, F0304, F0303, F0203 and F0202 that were distributed from April 29, 2019 to April 1, 2024.

BioZorb Implant Market Removal

After receiving nearly 300 reports of adverse events, the FDA issued a BioZorb Marker safety communication on October 25, urging physicians to return all unused implants to the manufacturer. Just weeks later, the FDA upgraded the recall to a Class I BioZorb recall on December 18, suggesting that continued use of the device poses a risk of severe injury or death.

Hologic reported that more than 90,000 BioZorb markers have been sold since 2015.

For individuals who already have a BioZorb Marker implanted, the FDA indicates they should report any adverse events to their healthcare provider. However, the agency indicates there is no need to have the device removed unless their doctor advises them to do so.

BioZorb Recall Lawsuits

Months before the recalls, dozens of BioZorb Marker lawsuits had already been filed by breast cancer survivors, alleging Hologic failed to adequately disclose risks to patients and the medical community. However, it is expected that the size and scope of the BioZorb recall lawsuits will expand dramatically in 2025.

To date, 22 BioZorb lawsuits have been filed on behalf of at least 100 different plaintiffs, which have been centralized for pretrial proceedings before U.S. District Judge Allison D. Burroughs in the District of Massachusetts, where the manufacturer’s headquarters are located.

As part of the pretrial proceedings, Judge Burroughs established a BioZorb lawsuit “bellwether” program, where the parties selected a small group of representative claims in August, which will go through pretrial motions and case-specific discovery in preparation for a series of early trial dates, which could begin as early as July 2025.

During a recent status conference, the parties updated Judge Burroughs on the status of discovery in the 10 bellwether selections, indicating that the cases are proceeding on schedule. Core depositions are expected to be complete by December 16, and each side will then strike three lawsuits from the discovery pool, resulting in four claims that will be eligible for the first trial dates.

Judge Burroughs had ordered the parties to file a case management order by December 19, identifying the four remaining bellwether trial cases and proposing a method for selecting the order in which the cases will go before juries. However, the parties are in disagreement on how to handle the multi-plaintiff complaints, indicating they will file competing proposed case management orders.

As the litigation moves forward, Biozorb implant lawyers continue to provide free consultations for women who have received a recalled tissue marker, and suffered any of the following injuries or complications:

• Migration
• Erosion
• Severe Pain
• Swelling
• Infections
• Necrosis
• Fluid buildup (Seroma)
• Removal surgery
• Other complications

Cartiva Implant Failure Recall

In October, another massive product recall was announced by the U.S. Food and Drug Administration (FDA), after Stryker announced a Cartiva toe implant recall over “higher-than-expected” rates of failure, which often required recipients to undergo revision or big toe fusion surgery.

The Cartiva Synthetic Cartilage Implant was approved by the FDA in 2016 and was designed to mimic the gel-like cushioning of natural cartilage, serving as a replacement for deteriorated cartilage in the big toe joint.

However, within just a few years of its introduction, patients who received the Cartiva toe implant began reporting high rates of complications, including severe toe pain, implant loosening, fractures and subsidence, which is where the implant sinks into the surrounding bone.

Stryker ultimately issued the Cartiva implant recall in October, citing newly published data and postmarket reports indicating that patients with Cartiva Synthetic Cartilage Implants (SCI) are experiencing higher-than-expected complication rates compared to those reported in the 2016 Premarket Approval (PMA).

In that same month, a new study was released indicating that Cartiva recipients faced a 30 times higher rate of reoperation than those who received alternative procedures, which was expected to provide important new evidence in the litigation.

Cartiva Implant Recall Lawsuits

Even before the recall was issued, multiple Cartiva implant failure lawsuits had been filed against Cartiva Inc., Wright Medical Group and Stryker, each claiming the companies misrepresented the safety and effectiveness of the synthetic cartilage implant.

Plaintiffs allege the device was defectively designed and inadequately tested, leading to a high rate of complications such as implant subsidence, loosening and severe pain. Furthermore, the lawsuits highlight the companies’ failure to disclose these risks and their continued promotion of the device despite mounting evidence of failures, causing patients to endure unnecessary suffering and additional corrective surgeries.

While multiple claims have been filed across various federal and state courts nationwide, the lawsuits have not been centralized before one judge for pretrial proceedings, which could result in inconsistent rulings, duplicative discovery efforts, increased litigation costs and delays in resolving the claims efficiently.

Cartiva implant lawyers are actively investigating new claims for individuals who have received a Cartiva implant, and suffered any of the following injuries:

• Implant Failure/Fracture
• Subsidence (implant sinks into the bone)
• Toe Fusion Surgery
• Replacement Surgery
• Revision Surgery

Impella Heart Pump Recall

In March 2024, the FDA announced a Class I recall for Abiomed’s Impella Left Sided Blood Pumps following at least 129 reports of serious injuries and 49 deaths linked to heart perforations, caused by the pump catheters piercing the wall of the left ventricle in the heart.

The Abiomed Impella pump is a cardiac support device designed to assist patients with severe heart conditions. These pencil-sized blood pumps are inserted into the heart’s left ventricle through the femoral artery and function by drawing blood from the ventricle and expelling it into the ascending aorta, ensuring oxygen-rich blood circulates throughout the body.

Impella devices are commonly used during cardiac procedures or when the heart requires support to maintain adequate blood flow, such as during high-risk percutaneous coronary interventions (PCI) or in treating cardiogenic shock, a condition where the heart suddenly fails to pump enough blood.

However, the devices have been linked to multiple recalls and warnings in recent years, raising safety concerns. In 2019, officials stated that while initial clinical trials reported a 73% survival rate among patients, real-world interim results from 2019 showed only a 28% survival rate among Impella patients transitioning to long-term therapy.

In 2023, Abiomed faced additional scrutiny after reports of purge fluid leaks in the Impella 5.5 with SmartAssist pumps, which could lead to device failure and heart valve damage. Although the company attempted to address the issue by updating the device’s instructions for use, the FDA later issued a recall due to persistent risks, including blood clot formation linked to inadequate labeling.

Impella Heart Pump Recall Lawsuit Investigation

Due to the growing number of recalls and warnings around the Impella heart pump device, lawyers are actively investigating potential Impella heart pump lawsuits for individuals who have suffered injuries and complications. There is increasing evidence that Abiomed’s Impella systems may pose risks of heart-wall perforations and other life-threatening issues, which may not have been adequately disclosed to patients or the medical community.

Impella heart pump lawyers are investigating claims for individuals who have suffered injuries linked to these devices, as well as wrongful death claims for families who lost loved ones due to complications allegedly caused by the Impella system.

Sterile Water and Saline Recall

While the original recall was announced in November 2023, officials updated a Nurse Assist sterile water and saline solution recall in April 2024, warning that multiple lots of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP may not be sterile and could potentially be contaminated with bacteria that could cause serious or life-threatening infections.

The recalled saline solutions are a mix of salt (sodium chloride) and purified water, commonly used for cleaning wounds or rinsing medical devices. They mimic the body’s natural fluids, making them gentle and safe for everyday use. In contrast, the recalled sterile water is pure water without any added salt, typically used in medical situations that require a completely salt-free liquid, such as preparing medications or cleaning sensitive areas.

The U.S. Food and Drug Administration (FDA) announced the initial Nurse Assist sterile water and saline recall on November 6, indicating the manufacturer found the packaging seal may potentially break and compromise the sterile barrier, which can introduce harmful bacteria into the solution.

While at the time of the recall there had not been any reported adverse events, the FDA later issued a Nurse Assist recall expansion in April 2024, after multiple illnesses had been reported in relation to the products, including bloodstream, urinary tract, open wound/soft tissue and respiratory infections.

The products were sold under a variety of brand names including Nurse Assist, Stericare, Cardinal Health, Covidien, Idex, McKesson, Mac Medical, Medline, SOL, Trudell, Vyaire, Halyard Owens Minor and Medichoice Owens Minor.

Sterile Saline and Water Recall Lawsuits

To date, only one Nurse Assist recall lawsuit has been publicly filed in connection with the saline and sterile water recall, but more claims are anticipated as awareness grows about the potential link between these products and severe infections.

Many individuals may not realize they were exposed to contaminated solutions, as infections are often attributed to the inherent risks of open wounds or medical procedures rather than specific product contamination.

However, hospitals have recently started notifying patients who were treated with the recalled saline or sterile water solutions, which may lead to more individuals identifying these products as the source of their infections, and subsequently pursuing compensation through a sterile water and saline recall lawsuit.

Oxbryta Recall

After only a few years on the market, Pfizer issued an Oxbryta recall in September 2024, indicating that a number of sickle cell patients were experiencing life threatening vascular events.

Oxbryta (voxelotor) was a prescription drug introduced by Global Blood Therapeutics in 2019, and was approved the FDA for the treatment of sickle cell anemia, which is a genetic disorder that affects red blood cells, causing them to assume a sickle shape that blocks blood flow and leads to severe pain and potential organ damage.

While the drug was quickly adopted by physicians across the U.S., Pfizer issued a global market recall of Oxbryta, warning that a number of sickle cell patients have experienced vaso-occlusive crises (VOCs), which are severe and painful episodes caused by the blockage of blood flow due to the clumping of sickle-shaped red blood cells in blood vessels.

Oxbryta Recall Lawsuits

Within a month of the recall, the first Oxbryta recall lawsuit was filed by a California resident who claims to have developed VOCs after beginning treatment, which resulted in the need for blood transfusions, severe pain and swelling.

The lawsuit is one of several filed by sickle cell patients in recent months, alleging that the manufacturers were aware of the risk of VOC side effects, yet placed a desire for profits before the health and safety of individuals with sickle cell disease.

As a result, lawyers are pursuing Oxbryta recall settlements for individuals who were prescribed the drug for the treatment of sickle cell disease and developed any of the following side effects, injuries, or severe complications:

• Vaso-occlusive crises (VOCs)
• Stroke
• Severe pain and swelling
• Death

Medical Device and Drug Recall Lawyers

If you or a loved one have been impacted by any of the recalled medical products or drugs, submit information about your potential claim for review by a lawyer to determine if you may be eligible for a product liability lawsuit settlement.

Lawyers provide free consultations to help determine if individuals may be eligible to file a claim, and there are never any fees or expenses unless a settlement is obtained in the case.