290 results

• Impella Recall Issued Over Guidewire Problems in RP Heart Pump With SmartAssist

  February 17, 2025

  Michael Adams

  An Impella heart pump recall has been issued to update use instructions for all Impella RP heart pumps with SmartAssist due to the risk of injury or death if the device contacts other medical equipment during certain procedures.

• FDA Issues Trokamed Nephroscope Sheath Kidney Rupture Warning After Patient Death

  December 23, 2024

  Martha Garcia

  The FDA is warning healthcare providers about the risks of misusing Trokamed nephroscope sheathes due to potential blockages that could lead to patient injuries and kidney ruptures.

• Problems With Recalled BioZorb Markers Could Cause Severe Injury or Death, FDA Warns

  December 19, 2024

  Irvin Jackson

  The FDA is giving a recent BioZorb marker recall a class I designation, indicating the federal agency believes problems with the device, implanted to assist in targeted therapy in breast cancer patients, can cause serious injuries and potentially death.

• Problems with Giraffe OmniBed Carestation Could Lead to Infant Injuries and Deaths, FDA Warns

  December 10, 2024

  Martha Garcia

  The FDA has designated recent instruction changes for GE Healthcare Giraffe Omnibed Incubators and Carestations as a class I recall, indicating formaldehyde emissions pose a risk of serious injury or death to newborns.

• BioZorb Recall Issued for All Breast Tissue Markers Following Implant Migration, Erosion Problems

  October 25, 2024

  Irvin Jackson

  The FDA is calling for doctors to stop using BioZorb Marker implants, due to serious complications in breast cancer patients, which has led Hologic to remove all remaining devices from the market.

• Medtronic Video Laryngoscopes Recall Results in “Do Not Use” Warning

  September 9, 2024

  Martha Garcia

  FDA has given a Medtronic video laryngoscope recall a class I designation, following reports that the batteries can overheat and explode, posing a risk of serious injury or death for patients.

• Medtronic NIM Vital Nerve Monitoring System Recall Issued After Injuries Reported

  August 8, 2024

  Martha Garcia

  The FDA has determined that a device correction issued for the Medtronic NIM Vital Nerve Monitoring System should be considered a Class I recall; indicating that problems with the medical device could lead to severe injuries and death.

• BioZorb Implant Complications Result in Lawsuit Brought by 7 Breast Cancer Survivors

  July 26, 2024

  Irvin Jackson

  A Biozorb tissue marker lawsuit filed by seven women claim the implant is defectively designed, and prone to cause a variety of complications, such as pain, lumps, device migration and infections.

• Baxter Life2000 Ventilator Recall Issued Over Battery Charging Problems Linked To Patient Injury

  July 17, 2024

  Grace Muller

  About 2,500 Baxter Life2000 ventilators are being recalled because the battery charging dongle can fail, resulting in patients not receiving life-sustaining oxygen, putting them at risk of severe injury and death.

• Lawsuit Alleges Recalled Torax LINX Failed, Resulting in Surgical Removal of Acid Reflux Device

  July 16, 2024

  Irvin Jackson

  According to allegations raised in a LINX reflux device lawsuit filed by a Texas woman, the esophageal implant was defectively designed, leading to the device's failure and the need for revision surgery.