FDA posts four device safety communications, prompting inventory, workflow checks

Editor's Note

The Food and Drug Administration (FDA) has issued four medical device recalls and early alerts between September 23 and 30, covering Automated Impella Controllers, Olympus ViziShot 2 FLEX (19G) endoscopic aspiration needles, 3M Ranger blood and irrigation fluid warming systems, and BD Alaris infusion pump sets. The notices detail affected products, reasons for action, and recommended steps for healthcare facilities.

Abiomed Impella controllers: The FDA issued an early alert on September 23, citing purge retainer failures in certain Automated Impella Controllers that can trigger purge pressure errors, alarms, interruptions in hemodynamic support, pump stop, and risk of permanent impairment or death. Five serious injuries and no deaths have been reported. Hospitals may continue using inventory while Abiomed services devices and replaces the purge retainer. Sites should coordinate returns with field service, disseminate the notice internally and to any transferees, complete the business response form, and report issues to MedWatch. Affected product codes include 0042-0000-US, 0042-0010-US, 0042-0040-US, 1000432, and 1000201, as detailed in the FDA alert.

3M Ranger blood and irrigation fluid warmers: On September 24, the FDA posted a labeling correction classified as the most serious type. Devices may remain in service with updated instructions. Actual warming performance is lower than prior labels at high flows, creating risk of hypothermia and death if operated outside updated specifications. Continue use with the corrected specs and retain the notice until new IFUs and manuals are available, per 3M’s April 21 customer letter summarized in the FDA update.

BD Alaris infusion sets: A September 29 updated alert describes subsets of compatible pump infusion sets performing outside published ranges for flow accuracy, bolus accuracy, occlusion time to alarm, and post-occlusion bolus. Variability is greatest with 0.2-micron filters at very low rates and can lead to under or over infusion, delayed alarms, and unintended boluses. No serious injuries or deaths have been reported. Use clinically appropriate alternate sets, prioritize critical care and pediatrics, consider syringe pumps when needed, and implement detailed risk mitigations from the v12.3 user manual, as outlined in the update.

Olympus ViziShot 2 FLEX (19G) needles: The FDA classified this as the most serious recall on September 30, for devices with potentially deformed a-traumatic tips that can lead to component ejection into the airways, mucosal injury, bleeding, infection, need for retrieval procedures, and death. There are 40 reported injuries and one death. Do not use affected lots (UDI 00821925043060; distributed August 4, 2022, to April 25, 2025). Quarantine inventory, follow IFU warnings, stop if resistance is encountered, inspect after each pass, arrange RMA via Olympus, and acknowledge recall number 0473, per the recall notice.