FDA-Device2022-12-21Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
ARROW INTERNATIONAL Inc.
Hazard
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Sold states
Worldwide
Affected count
N/A
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0437-2023Don't want to check this manually?
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