FDA-Device2022-12-21Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), 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
39 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0447-2023Don't want to check this manually?
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