290 results

• FDA Issues “Do Not Use” Warning for Recalled Medtronic NIM Endotracheal Tubes

  July 10, 2024

  Irvin Jackson

  The FDA is warning healthcare providers not to use Medtronic NIM endotracheal tubes following dozens of reports of the devices losing functionality and degrading, which could prevent life-saving oxygen from being supplied to patients during surgery.

• LINX Device Lawsuit Alleges GERD Implant Broke and Failed Due to Manufacturing Defects

  June 28, 2024

  Russell Maas

  A Minnesota man has filed a LINX reflux lawsuit against Ethicon and Torax Medical, after a LINX device meant to help treat GERD, broke inside of him, requiring surgical removal.

• LINX Reflux Implant Lawsuit Alleges Device Was Defectively Manufactured, Resulting in Recurrence of GERD and Surgical Removal

  June 4, 2024

  Irvin Jackson

  A Pennsylvania woman has filed a product liability lawsuit against Ethicon after a LINX implant, meant to help treat GERD, broke inside of her, requiring surgical removal.

• Medline SubG Endotracheal Tube Recall: Inflation Problem Presents Health Risks

  June 3, 2024

  Grace Muller

  The FDA has announced a recall of SubG Endotracheal Tubes with Subglottic Suction and kits that contain these devices due to a risk of tearing, loss of inflation, and severe patient injury risks.

• BioZorb Marker Recall Issued After Dozens of Injuries Linked to the Radiographic Implants

  May 23, 2024

  Grace Muller

  Nearly 54,000 BioZorb Markers, used in breast cancer treatment, are being recalled following dozens of reports of injuries, including implant migration.

• CDC Report Details Medtronic Duet EVD Infection Outbreak At Rhode Island Hospital

  April 12, 2024

  Irvin Jackson

  A new CDC reports highlights how disconnections and leaks led to a recall of Medtronic Duet EVD systems due to the risk of brain fluid infections.

• Impella Left Sided Blood Pump Recall Issued Over Risk of Perforations Due to Faulty Instructions

  March 25, 2024

  Hannah Brown

  The Impella Left Sided Blood Pump recall warns that the device has been linked to heart perforations, resulting in severe injuries and deaths.

• HeartMate Touch Communication System Recall Issued After Reports of Injuries

  March 12, 2024

  Hannah Brown

  The FDA has announced a recall of more than 1,500 HeartMate 3 Touch Communication Systems, indicating that problems with the device may lead to serious patient injuries or death.

• ResMed CPAP Mask Recall Issued Due To Risk Magnets May Interfere with Medical Devices

  January 12, 2024

  Russell Maas

  More than 20 million ResMed AirFit and AirTouch CPAP and BiPAP facemasks have been recalled over the potential for the magnetic masks to interfere with implantable medical devices.

• Fresenius Gets FDA Warning Letter Over Hemodialysis Recall Problems

  December 27, 2023

  Katherine McDaniel

  The FDA has sent a warning letter to Fresenius over its recalled hemodialysis machine, indicating the manufacturer knew for years that the tubing could release dangerous PCBs into patients' blood.