Health product recall

Autocat 2 Systems

Last updated

Summary

Product
Autocat 2 Systems
Issue
Medical devices - Performance
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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