The FDA has flagged five medical device recalls and early alerts over the past week, covering breathing systems, central venous catheters, convenience kits, heart pump controllers and bag-valve-mask resuscitators.
Here are five to know:
- Breathing systems (Intersurgical): On Nov. 10, the FDA issued an early alert after Intersurgical asked customers to remove certain 22-millimeter Smoothbore breathing tubes and systems, including single- and dual-heated wire systems. The company said the solvent used to bond the soft connectors to the tubing during manufacturing may cause them to detach, which could lead to loss of ventilation, brain damage or death. Intersurgical sent its customer letter Nov. 3 and had reported no serious injuries or deaths as of that date. Customers should return the affected products.
- Peripherally inserted central catheters (Arrow International): On Nov. 10, the FDA issued an early alert after Arrow International, a Teleflex subsidiary, told customers to remove certain products containing hydrophilic-coated spring wire guide components, including one-lumen and three-lumen pressure-injectable PICCs with 80-centimeter and 130-centimeter wires. Arrow said the coating may detach and release particles into the bloodstream, posing a risk of embolism. Customers should quarantine affected devices and return them. Arrow sent its letter Nov. 5 and had reported no serious injuries or deaths.
- Convenience kits (Cardinal Health): On Nov. 9, the FDA confirmed a recall of Cardinal Health Presource packs containing BD Alaris pump infusion sets after issuing early alerts Oct. 20. Cardinal told customers to quarantine the kits and label them so clinicians discard the recalled sets. The company also directed customers to BD’s updated performance data and advised them to use an alternative pump when the sets’ performance is not clinically appropriate. As of Aug. 19, BD had reported no serious injuries or deaths.
- Heart pump controllers (Abiomed): On Nov. 9, the FDA classified Abiomed’s removal of certain Automated Impella Controllers as a Class I recall, its most serious recall type, after issuing an early alert Sept. 23. Abiomed said a retrospective review of servicing records found controllers that need hardware, firmware or software updates to address quality issues with potential safety implications. The company sent its customer letter Sept. 18 and had reported no serious injuries or deaths as of Sept. 8.
- Bag-valve-mask resuscitators (Compact Medical): On Nov. 3, the FDA issued an early alert after Compact Medical told customers to remove nine lots of its ButterflyBVM single-use resuscitators, lots 000109 through 000117, because a hole may form in the bellows. The company also told customers to follow updated use instructions for other affected lots, including conducting a pre-use test before each patient. Customers should confirm backup resuscitators are available before removing units. Compact Medical had reported no serious injuries or deaths as of Nov. 2.
