Health product recall

Autocat 2 Systems

Last updated

Summary

Product
Autocat 2 Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Autocat 2 Wave More than 10 numbers, contact manufacturer. IAP-0500
Autocat 2 Intraaortic Balloon Pump 070415V 70312V 61041V 41206V 070733V 080732V 50525V 40638V IAP-0400
Ac3 Optimus Iabp More than 10 numbers, contact manufacturer. IAP-0700

Issue

Teleflex has initiated a voluntary field safety corrective action due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an ac power source or with battery power for mobile use. When operating the IABP device using battery power, the expected duration of pumping, after a full charge, is 90 minutes. However, Teleflex has received complaints reporting that some users of the affected IABP devices have experienced short battery run-times, including loss of power during use.

Recall start date: November 7, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Arrow International Llc Subsidiary Of Teleflex Incorporated

3015 Carrington Mill Blvd., Morrisville, North Carolina, United States, 27560

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-72219

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