13 medical device recalls to know

The FDA has flagged 13 medical device recalls, corrections and early alerts over the past two weeks, affecting spinal cord stimulators, patient monitoring systems, convenience kits, catheters, breathing circuits, ventilators and heart pumps.

Here are the 13 to know, split into confirmed recalls/corrections and early alerts, in order of most recent first:

Recalls and corrections confirmed

1. Spinal cord stimulator leads (Boston Scientific): On Sept. 3, the FDA confirmed the removal of unused Infinion CX Leads, a component of the company’s spinal cord stimulator system used to manage chronic back and limb pain. The recall does not affect already-implanted leads; reported injuries linked to electrical signal disruption or lead-wire fracture number more than 1,000.
2. Patient monitoring software (GE HealthCare): On Sept. 3, the FDA confirmed a correction updating use instructions for Portrait Mobile Monitoring Solution devices running certain versions of Portrait Core Services software, after the company found some monitored patients may not have been receiving continuous readings as expected. Affected devices may remain in use with alternative monitoring in place during software updates.
3. Electrophysiology and ultrasound catheters (Medline Industries): On Sept. 2, the FDA confirmed an expanded recall of certain reprocessed catheters after finding they may contain residual particulates, which carries a risk of infection, embolism or thrombosis.
4. Convenience kits (AVID Medical): On Aug. 27, the FDA confirmed a correction for kits containing Namic Star Off Handle manifolds affected by a separate Medline recall, after particulate was found within the manifolds’ fluid path. As of June 30, AVID Medical had reported no serious injuries or deaths.

Early alerts, still under FDA review

8. Breathing circuits (Draeger): On Sept. 3, the FDA flagged VentStar Resus Neo hoses, used to deliver breathing gas to infants up to 22 pounds, over reports of cracking or hose detachment. As of Aug. 27, Draeger had reported no serious injuries or deaths.
9. IV start kits (Avid Medical): On Aug. 28, the FDA flagged convenience kits affected by the BD ChloraPrep applicator recall, with instructions updated to require destroying the entire kit rather than removing just the affected component.
10. Angiographic catheters (Boston Scientific): On Aug. 28, the FDA flagged all Imager II Angiographic Catheters for removal after finding they were manufactured with reduced stabilizing agents in the tips, raising the risk of tip degradation and detachment; the company is also discontinuing the product.
11. Esophageal pH monitoring capsule delivery devices (Medtronic and Given Imaging): On Aug. 27, the FDA flagged Bravo CF capsule delivery devices that can fail to attach to the esophagus or detach from the delivery device, risking aspiration, esophageal perforation or laceration. As of Aug. 10, Medtronic had reported 184 serious injuries and no deaths.
12. Heart pump controllers (Abiomed): On Aug. 26, the FDA flagged Automated Impella Controllers over purge cassette recognition failures that could delay mechanical circulatory support. As of Aug. 17, Abiomed had reported 37 serious injuries and three deaths.
13. Ventilators (CooperSurgical): On Aug. 24, the FDA flagged the INCA Infant Nasal CPAP Assembly over a loose tubing connection issue. As of Aug. 11, the company had reported no serious injuries or deaths.

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