Search FDA recalls and reported device problems across perfusion products and equipment.
Understand the source. FDA recall records and MAUDE adverse-event reports are different. A MAUDE report does not establish that a device caused an event. Report counts are not failure rates or comparisons of product safety. Confirm affected models, lots, and current instructions in the original FDA/manufacturer notice.
FDA notices & alerts
Selected official notices and FDA recall records · reviewed November 4, 2026. Publication/update dates may differ from the original manufacturer action date. Older references retain their dates.
Class I recall · newFDA public notice October 30, 2026 · firm action initiated September 3, 2026
HemosIL AcuStar HIT-IgG(PF4-H) assay
FDA identified the recall as Class I after performance variability in four affected lots could produce negatively biased results and potentially report a sample below the assay cutoff. FDA lists lots B40005, B40006, B38062 and B38063. Review the original notice for the exact parts, UDIs, destruction instructions and transition to an alternative HIT antibody-testing method.
Read FDA recall noticeFDA early alert · recent referenceFDA posted October 15, 2026 · manufacturer letter October 5, 2026
Edwards Commander M delivery systems for SAPIEN M3
FDA identified a potentially high-risk issue affecting specified Commander M delivery-system lots after reported balloon bursts during inflation. The alert lists lots 67718561, 67804014, 67887043 and 67887044 and says other lots are not affected. Review the original notice for the exact scope and current removal/return instructions.
Read FDA early alertFDA recall database · recent referenceFDA posted October 15, 2026 · firm action initiated August 18, 2026
Radiometer ABL90 FLEX / FLEX PLUS analyzer correction
The FDA recall record describes potentially inaccurate results and changes to sample types, reportable ranges, analyzer configuration, limitations and warnings for software versions 3.6 and lower. Review the original record for the affected UDI-DIs, instructions-for-use versions and customer actions; no severity class is inferred here.
Read FDA recall recordClass I recall · October referenceFDA updated October 14, 2026 · early alert August 28, 2026
FDA confirmed Class I status for AVID kit KRIV26-02, lot 1658437. The affected-product and whole-kit disposal guidance remains on the FDA page. This supports vascular-access inventory review; it is not a CPB-console notice.
Read FDA noticeClass I recall · October referenceFDA updated October 13, 2026 · early alert August 24, 2026
The related FDA update concerns specified Medline kits containing ChloraPrep applicators with potential fungal contamination. It is part of the same component issue as the AVID notice, not evidence of a separate new incident.
Read FDA noticeClass I recall notice · older referenceFDA updated September 24, 2026 · early alert September 3, 2026
Abiomed Automated Impella Controllers
FDA describes purge-cassette recognition problems and a phased service process for affected controller models. Three related FDA database product records posted October 28; the underlying public notice remains an older reference, not a newly discovered warning.
Read FDA noticeFDA provider letter · older referenceMay 8, 2024
Getinge Cardiohelp / HLS sets and Cardiosave IABPs
FDA’s provider letter addresses persistent safety and quality concerns, alternative-equipment planning and reporting. This is an older reference; review the official page and any newer device-specific notices.
Coverage: the current 876-item catalog and the page’s 17 device groups informed this review. The added coagulation/HIT testing group includes the verified FDA LCO product code. FDA recall/early-alert, safety-communication and provider-letter sources were checked; manufacturer-site searches were bounded. FDA recall data were updated October 31, 2026; MAUDE data were updated October 20, 2026. The newest 100 of 1,054 matching MAUDE reports received September 22–November 4 were reviewed, and all 20 records in the prior displayed event snapshot remained in that overlap. Older supplementary changes may be missed. Report counts are not incident counts or comparative device risk.
Coverage: CPB machines and pumps; ECMO/ECLS and oxygenators; heater-coolers; cannulas; circuits, reservoirs and filters; monitoring and gas delivery; hemoconcentrators; cardioplegia; cell salvage; ACT and viscoelastic testing; coagulation and HIT testing; VADs, Impella and balloon pumps; CRRT and hemofiltration; rapid infusers and blood warmers; cerebral oximetry/NIRS; pressure and flow monitoring; organ preservation and ex vivo perfusion. Searches use the FDA product codes listed below and are not guaranteed to capture every relevant device or report. Supporting equipment may have uses outside perfusion. Hemoconcentrator and CRRT searches narrow their shared dialysis classification using device-name terms. General infusion-pump classification searches are narrowed to rapid-infuser names. Multiple reports may describe the same incident, and recalls may have separate records for affected products.Monitored FDA product codes
Data source: FDA/openFDA. New data are published on the FDA’s schedule. IPA reviews this resource for the weekly newsletter. Recalls are sorted by initiation date; MAUDE reports by date received. Date filters use those dates. This is an educational resource; follow the current official notice and your institution’s procedures.
PerfusionGPT AssistantEducation · Research · Global cardiac care
Educational information only. Follow your institution’s clinical protocols. Please do not share patient information. Document search is being connected.
