The FDA has flagged three medical device recalls and corrections confirmed over the past week, affecting angiographic catheters, heart pump controllers and convenience kits. The convenience kit correction is the latest in a chain of recalls tied to sodium chloride ampules manufactured by Huons Co.
Here are the three to know, in order of most recent first:
- Angiographic catheters (Boston Scientific): On Sept. 25, the FDA classified as its most serious recall type Boston Scientific’s removal of all Imager II Angiographic Catheters, manufactured with reduced levels of stabilizing agents in the tips that can increase the risk of tip degradation and detachment. As of July 16, the company had reported two serious injuries and no deaths and is discontinuing the product line.
- Heart pump controllers (Abiomed): On Sept. 24, the FDA classified as its most serious recall type Abiomed’s removal of Automated Impella Controllers over purge cassette recognition failures tied to a faulty purge flag component, which can delay or interrupt mechanical circulatory support. The company has reported 37 serious injuries and three deaths linked to the issue.
- Convenience kits (Becton Dickinson): On Sept. 24, the FDA classified as its most serious recall type a correction for BD convenience kits and procedure trays containing Huons-manufactured sodium chloride ampules, warning the ampules may expose patients to microorganisms, endotoxins or foreign matter. The ampule is the only affected component; other kit contents can continue to be used once removed.
