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Autocat 2 systems

Official notice

24 Nov 2022

Last checked

24 Nov 2022

High riskHealth Canada

An official Health Canada notice concerns Autocat 2 systems. 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 Published 2022-11-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72219

Official notice

2022-11-24

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

72219

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Affected products

Product 1

Affected products - Autocat 2 Wave, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - IAP-0500

Product 2

Affected products - Autocat 2 Intraaortic Balloon Pump, Lot or serial number - 070415V 70312V 61041V 41206V 070733V 080732V 50525V 40638V, Model or catalogue number - IAP-0400

Product 3

Affected products - Ac3 Optimus Iabp, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - IAP-0700

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Arrow Subsidiary Of Teleflex, Autocat 2.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

72219

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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