5 medical device recalls to know

So far in May, the FDA has flagged five medical device recalls, corrections and early alerts affecting cryoprobes, wound dressings, catheters, infusion pumps and stents.

Here are the five recalls to know:

1. Pacemakers (Boston Scientific): On May 7, the FDA confirmed a Class I recall involving a correction to all Accolade pacemakers and CRT-Ps. A battery issue can cause devices to permanently enter Safety Mode, which has limited functionality and may leave the pacemaker unable to properly regulate heart rhythm. Boston Scientific is recommending all affected devices be upgraded to Brady SMR6 software. The FDA reported 2,557 serious injuries and four deaths.
2. Convenience kits (Medical Action Industries): On May 7, the FDA confirmed a Class I recall of Cath Pack convenience kits containing Namic RA syringes affected by a Medline recall. The syringe rotating adaptor may unwind during use, resulting in loose connections or disconnection that could lead to blood loss, infection or air embolism. The FDA reported four serious injuries and no deaths.
3. Convenience kits (American Contract Systems): On May 7, the FDA confirmed a Class I recall of Coronary Angio Pack convenience kits also containing the affected Namic RA syringes. The same rotating adaptor defect may cause loose connections or disconnection, posing risks of blood loss, infection or air embolism. The FDA reported four serious injuries and no deaths.
4. Surgical stapler reloads (Intuitive Surgical): On May 5, the FDA confirmed a Class I recall of 8mm SureForm 30 Gray Reloads for curved-tip staplers used with the da Vinci Surgical System. The company identified instances of incomplete staple lines on blood vessels, which could cause bleeding and may require conversion from robotic to open surgery. The FDA reported four serious injuries and one death.
5. Sizing catheters (Cook Medical): On May 5, the FDA confirmed a Class I recall of various Centimeter Sizing Catheters, Aurous Centimeter Sizing Catheters and Beacon Tip Centimeter Sizing Catheters. The marker bands on affected devices may be at increased risk of cracking or breakage, which could lead to device fragmentation, vessel injury or, in a worst-case scenario, life-threatening harm. The FDA reported no serious injuries or deaths.

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