Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2417-2020 — Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

U.S. FDA — Device Enforcement · United States · 2020-05-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2417-2020
Date of alert
2020-05-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.