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 · reviewed October 14, 2026. FDA publication/update dates differ from the original manufacturer action date. Older references retain their dates.
Class I recall · classification updateFDA updated October 14, 2026 · early alert August 28, 2026
FDA confirmed Class I status for affected AVID kit KRIV26-02, lot 1658437. This supports vascular-access inventory review; it is not a CPB-console notice. The FDA page retains the existing affected-product and whole-kit disposal guidance. Check the original notice for precise scope and required actions.
Read FDA noticeClass I recall · classification updateFDA updated October 13, 2026 · early alert August 24, 2026
The related FDA classification update concerns specified Medline kits containing ChloraPrep applicators with potential fungal contamination. Affected-product and whole-kit disposal instructions remain unchanged. This 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 associated with failure of a component in the pressure-sensing assembly. The notice explains the phased service process and affected controller models. Retained for awareness; this is 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 828-item catalog and the page’s 16 device groups informed this review. FDA recall/early-alert, safety-communication and provider-letter sources were checked; manufacturer-site searches were bounded. MAUDE overlap: 100 reports received September 15–October 14 were reviewed; 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; 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.
