The FDA has flagged six medical device recalls and early alerts over the past two weeks, covering a mitral valve delivery system, a portable ultrasound, IV and infusion pump sets and two sets of convenience kits tied to the same recalled skin prep applicators. Here are the six to know:
- Transcatheter mitral valve delivery system (Edwards Lifesciences): On Oct. 15, the FDA issued an early alert after Edwards asked customers to remove four lots of Commander M delivery systems used with its Sapien M3 transcatheter mitral valve replacement system. Edwards received three reports of balloons bursting during inflation, which can cause embolism or leave the device unable to be retrieved, potentially requiring surgery. As of Oct. 5, the company had reported one death and one serious injury.
- Convenience kits (AVID Medical): On Oct. 14, the FDA classified AVID Medical’s removal of certain convenience kits containing recalled BD ChloraPrep applicators as its most serious recall type. The applicators may be contaminated with the fungus Aspergillus penicillioides. AVID told customers Aug. 20 to destroy entire kits, replacing an earlier instruction to over-label and remove only the applicator. As of Aug. 20, AVID had not reported any serious injuries or deaths.
- Convenience kits (Medline): On Oct. 13, the FDA classified Medline’s removal of convenience kits containing recalled BD ChloraPrep Clear 1 milliliter and FREPP Clear 1.5 milliliter applicators as its most serious recall type. BD recalled the applicators over a potential breach of sterility in the packaging. As with AVID, Medline’s instructions moved from removing only the applicator to destroying the whole kit.
- Diagnostic ultrasound system (Philips Ultrasound): On Oct. 9, the FDA issued an early alert after Philips updated use instructions for all Lumify diagnostic ultrasound systems. A software issue can cause the app to stop recognizing a previously registered transducer and prompt re-registration, which requires a Wi-Fi or cellular signal. Philips has reported four deaths and eight serious injuries as of Sept. 29. It advises using Lumify only where a signal is readily available unless a backup device is on hand while it develops a software update.
- IV tubing sets (ICU Medical): On Oct. 5, the FDA listed ICU Medical’s correction updating use instructions for certain IV tubing sets after reports of black specks, discoloration and particulate matter in drip chambers. ICU Medical completed its investigation and no longer recommends enhanced inspections. It now advises setting aside any device with loose particulate matter in the fluid path and contacting the company and says products can otherwise continue to be used per instructions. As of July 16, it had reported no serious injuries or deaths.
- Infusion sets (BD and CareFusion 303): On Oct. 5, the FDA classified an updated BD action on Alaris pump infusion sets compatible with the Alaris Pump Module model 8100 as its most serious recall type. BD said some sets with restrictive components, such as filters, check valves and microbore tubing, perform worse than previously disclosed and is removing and discontinuing certain sets. It advises switching to an alternative pump, such as the Alaris syringe module, when performance is not clinically appropriate. As of Aug. 19, BD had not reported any serious injuries or deaths.
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