Medical device recalls are essential to patient safety, addressing critical issues in devices that may pose health risks.
Here are some of the most recent recalls reported to the FDA:
Zoll recalls Autopulse NXT resuscitation system for risk of inadequate CPR
Zoll Circulation is recalling its AutoPulse NXT Resuscitation System due to a failure code that can result in stopped or inadequate chest compressions. The malfunction may delay lifesaving CPR and could lead to serious harm such as anoxic brain injury or death. Customers were advised on March 4 to immediately discontinue use and return affected devices There have been no reported injuries or deaths.
Medtronic recalls Bravo CF capsule delivery device for risk of airway or esophageal injury
Medtronic and Given Imaging are recalling Bravo CF capsule delivery devices due to a manufacturing issue that may prevent the capsule from attaching or detaching properly. Risks include airway obstruction, aspiration, esophageal perforation and bleeding. Medtronic sent urgent notices starting June 3, asking customers to quarantine and return affected devices. A total of 33 injuries have been reported.
Cook Medical recalls Beacon Tip Angiographic Catheters due to tip separation
Cook Medical is recalling certain Beacon Tip 5.0 Fr Angiographic Catheters following reports of tip separation during or before use. Tip detachment can result in catheter fragmentation, embolism, vessel damage or cardiac complications. On May 15, Cook Medical advised all customers to stop using and quarantine all affected devices. Three serious injuries have been reported.
