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MedWatch Safety Alert

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication

Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.

Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding

Obsidio Embolic may cause bowel ischemia if used with the aliquot technique to address lower GI bleeding.

Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death

Fresenius Kabi is recalling Ivenix Infusion System (IIS), LVP, due to several software issues that could cause serious harm or death to patients.

Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication

Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection.

Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction

HeartMate II and HeartMate 3 devices are being recalled because a buildup of biological material is obstructing the device, making it more difficult for the heart to pump blood.

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP

Northfield, Ill., Apr. 5, 2024 – In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded conveni