Surgery Staples Lawsuits

Background information on Surgery Staples lawsuits, settlements and litigation updates published between 2012 to 2021.

Surgery Staples Lawsuit Overview

The surgical stapler litigation focused on claims that defective staplers and staples used during surgical procedures caused severe internal injuries, infections, and deaths.

Manufactured by major companies such as Medtronic and Ethicon, the devices were designed to close incisions and reconnect tissue during operations. However, patients and surgeons later reported cases of misfired staples, incomplete closures, and detached lines that resulted in internal bleeding, sepsis, and the need for additional surgeries. Allegations surfaced that the manufacturers were aware of high malfunction rates but failed to adequately warn hospitals or disclose the full scope of reported problems.

The controversy deepened after investigative reports revealed that thousands of surgical stapler malfunctions had been hidden from the public through the FDA’s internal “alternative summary reporting” system. Once the data was made public, the FDA reclassified surgical staplers as Class II medical devices in 2019, requiring stricter safety oversight and reporting standards. Lawsuits were subsequently filed nationwide accusing the manufacturers of negligence, design defects, and failure to warn about the risks of staple misfires and malfunctions.

Many of the cases were centralized in state and federal courts, where plaintiffs alleged catastrophic injuries such as organ perforations and internal hemorrhaging. While the litigation remains ongoing in some jurisdictions, several settlements have been reached to compensate affected patients.

Surgical Staples Lawsuit Examples

December 5, 2024: Covidien Surgical Stapler Malfunction Lawsuit Filed Over Internal Injuries

A new lawsuit accused Medtronic’s Covidien unit of manufacturing a defective surgical stapler that malfunctioned during abdominal surgery, allegedly causing severe internal bleeding and infection. The plaintiff claimed that the stapler’s design flaws led to an anastomotic leak requiring emergency treatment.

November 12, 2024: Covidien Surgical Stapler Lawsuit Alleges Device Failure Caused Severe Complications

A patient filed a lawsuit claiming that a Covidien surgical stapler misfired during gastrointestinal surgery, resulting in internal bleeding and sepsis. The complaint alleged that Medtronic and its Covidien subsidiary sold unsafe staplers without properly disclosing known risks to surgeons.

October 18, 2024: Lawsuit Filed After Covidien Surgical Stapler Broke During Operation

A malpractice and product liability lawsuit was filed after a Covidien surgical stapler broke mid-procedure, causing significant tissue damage and post-operative infection. The plaintiff argued that the company failed to recall earlier defective batches linked to similar malfunctions.

September 2, 2024: Surgical Stapler Sepsis Lawsuit Filed Over Post-Operative Infection

A lawsuit alleged that a defective surgical stapler caused an intestinal leak that led to a life-threatening sepsis infection. The filing claimed that both the hospital and the device manufacturer ignored red flags about faulty stapling mechanisms and improper sealing.

March 20, 2023: Surgical Stapler Lawsuit Filed Over Abdominal Leak Injuries

A patient filed a lawsuit claiming a defective surgical stapler caused an abdominal leak following a gastrointestinal procedure. The complaint alleged that device misfires allowed intestinal contents to escape, leading to infection and extended hospitalization.

December 8, 2022: Endo GIA Surgical Stapler Lawsuit Alleges Device Malfunction During Surgery

An Endo GIA stapler was at the center of a lawsuit filed by a patient who suffered severe bowel complications after the device failed to seal properly during surgery. The plaintiff accused Medtronic of producing a dangerously unreliable medical instrument.

March 15, 2021: Ethicon Surgical Stapler Lawsuit Filed Over Bowel Leak and Sepsis

A lawsuit was filed against Ethicon claiming a Proximate surgical stapler malfunctioned during an intestinal surgery, causing a bowel leak that led to sepsis and permanent health problems. The suit alleged defective design and inadequate post-market testing.

February 9, 2020: Endo GIA Stapling Lawsuit Filed Following Intestinal Leak

A patient sued Medtronic after an Endo GIA surgical stapler failed to properly close tissue, resulting in a serious infection. The lawsuit alleged that the device’s misfire caused an anastomotic leak and required multiple corrective surgeries.

November 13, 2019: Ethicon Surgical Stapler Malfunction Lawsuit Filed Over Bowel Leak

A patient filed a claim against Ethicon, alleging that a surgical stapler misfire caused a bowel leak and subsequent infection. The lawsuit accused the company of selling defective devices and failing to warn about risks linked to manufacturing errors.

September 27, 2019: Lawsuit Filed Over Surgical Staple Gun Misfire During Procedure

A complaint was filed after a surgical stapler allegedly misfired, causing an incomplete tissue seal and post-operative infection. The plaintiff alleged that both the product’s design and lack of recall contributed to the injury.

July 10, 2019: Lawsuit Alleges Surgical Stapler Malfunction Caused Bowel Leak

A woman filed a product liability lawsuit against Ethicon, claiming that a defective stapler malfunctioned during surgery and caused a bowel leak. The complaint alleged that Ethicon ignored reports of similar malfunctions and concealed evidence from surgeons.

June 3, 2019: Lawsuit Filed Over Ethicon Surgical Stapler Misfire During Surgery

An Ethicon Proximate surgical stapler allegedly misfired during a gastrointestinal procedure, resulting in internal bleeding and infection. The lawsuit accused the company of negligence in testing and manufacturing its surgical staplers.

March 6, 2016: Jury Awards $5 Million Verdict in Ethicon Surgical Stapler Lawsuit

A California jury awarded $5 million to a woman injured by an Ethicon surgical stapler that malfunctioned during surgery. The verdict found that the stapler’s misfire caused severe internal injuries, highlighting long-standing safety concerns about the device’s reliability.

April 21, 2014: Ethicon Proximate Stapler Lawsuit Filed Over Surgical Misfire

A lawsuit was filed alleging that an Ethicon Proximate surgical stapler misfired during an operation, resulting in internal bleeding and organ damage. The plaintiff claimed the device’s failure was due to design flaws that Ethicon failed to correct despite earlier reports of malfunction.

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Surgical Stapler Recalls and Warnings

November 6, 2023: Ethicon Surgical Stapler Reloads Recalled After Patient Death

Ethicon announced a Class I recall of its surgical stapler reloads following a patient’s death linked to device failure during surgery. The company warned that misfiring staplers could cause bleeding, leaks, or tissue trauma, requiring emergency reoperations and posing life-threatening risks.

October 7, 2019: Ethicon Recalls Echelon Flex Surgical Staplers Over Malformation Risks

Ethicon issued a recall for certain Echelon Flex Endopath staplers after reports revealed the devices could form malformed staples, resulting in leaks or internal bleeding. The FDA classified it as a Class I recall due to the potential for serious surgical injuries and fatalities.

May 16, 2019: Ethicon Circular Stapler Recall Announced for Tissue Damage Risk

The FDA announced a nationwide Class I recall of Ethicon circular staplers used in gastrointestinal surgeries after discovering they could fail to properly form staples. Malfunctions led to several reports of major bleeding, sepsis, and at least two deaths linked to the defective devices.

March 25, 2015: TigerPaw Surgical Staple Recall Issued Due to Malfunctions During Heart Surgery

The FDA announced a Class I recall for the TigerPaw System II surgical staple device after reports of the implant failing to properly close left atrial appendages during heart surgery. The failures caused tissue tears and severe bleeding, prompting urgent removal from the market.

December 18, 2012: Stolen Covidien Surgical Staple Warning Issued by FDA

Federal regulators warned hospitals and surgical centers about stolen Covidien Endo GIA staplers that may have been resold without proper sterilization or quality control. The FDA cautioned that the devices posed significant infection and malfunction risks if used in procedures.

February 17, 2012: Ethicon Stapler Recall Over Misfiring and Bleeding Complications

Ethicon recalled several models of its surgical staplers after identifying a defect that could cause incomplete staple formation. The company warned that device misfires during surgery could lead to internal bleeding and extended hospital stays.

January 24, 2012: Proximate Surgical Stapler Recall Issued Following Reports of Malfunctions

Ethicon recalled Proximate surgical staplers after discovering certain lots failed to fire properly, risking serious surgical complications. Surgeons were advised to immediately stop using affected batches and return the recalled products for replacement.

December 19, 2011: Covidien Roticulator Surgical Stapler Recall Announced Due to Firing Malfunctions

Covidien recalled its Roticulator Endo surgical staplers after identifying manufacturing defects that caused incomplete staple formation. The FDA classified it as a Class I recall, citing risks of hemorrhage and organ injury during surgical procedures.

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Surgical Stapler Research and Reports

August 3, 2021: FDA Finalizes New Rules for Surgical Stapler Safety Oversight

The FDA issued new regulations reclassifying surgical staplers as Class II medical devices, subjecting them to stricter safety and performance requirements. The move came after years of criticism that the devices were inadequately regulated despite thousands of reports of serious injuries and deaths.

October 3, 2019: FDA Warns Surgical Staplers Pose Serious Health Threat to Patients

Federal health officials issued an updated safety warning, citing over 41,000 reports of surgical stapler malfunctions between 2011 and 2018. The agency said misfires, malformed staples, and internal bleeding continued to pose a major risk to patient safety, prompting renewed calls for tighter oversight.

August 23, 2019: Lawsuit Highlights Growing Concern Over Surgical Staple Complications

A newly filed lawsuit underscored the frequency of catastrophic injuries caused by defective surgical staplers. Attorneys noted that many patients suffered internal bleeding, sepsis, or death due to misfires that were allegedly underreported to regulators.

May 31, 2019: FDA Holds Hearing on Risks Linked to Surgical Staplers

An FDA advisory panel met to discuss the widespread underreporting of stapler malfunctions and potential new safety regulations. Experts reviewed data showing that device failures frequently resulted in organ damage, uncontrolled bleeding, and fatalities.

May 2, 2019: FDA Accused of Hiding Thousands of Surgical Stapler Malfunction Reports

An investigation revealed that the FDA had placed more than 56,000 reports of stapler-related injuries into a hidden internal database, shielding them from public view. The disclosure sparked outrage among patient advocates and lawmakers demanding greater transparency in medical device reporting.

March 11, 2019: FDA Proposes New Rules to Strengthen Surgical Stapler Oversight

The FDA proposed reclassifying surgical staplers to increase manufacturer accountability and public reporting of adverse events. The rule change aimed to prevent repeat misfires and reduce the number of severe injuries linked to the devices each year.

February 25, 2019: Study Warns of Hidden Dangers Associated With Surgical Staplers

Researchers warned that surgical staplers were responsible for thousands of preventable injuries due to misfires and manufacturing flaws. The report urged healthcare facilities to adopt stricter training and called for mandatory reporting of all device malfunctions to the FDA.