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

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I — recall Z-2412-2020

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-2412-2020
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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