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Ultra intra-aortic balloon pumps (iabp)

Official notice

7 May 2024

Last checked

7 May 2024

High riskHealth Canada

An official Health Canada notice concerns Ultra intra-aortic balloon pumps (iabp). Teleflex is initiating this voluntary correction for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: failure of the intra-aortic balloon to completely inflate over its full length damaged or broken central lumen in the segment contained within the balloon helium loss or blood in the helium pathway Recall start date: April 30, 2024 Published 2024-05-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75492

Official notice

2024-05-07

The hazard

Teleflex is initiating this voluntary correction for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: failure of the intra-aortic balloon to completely inflate over its full length damaged or broken central lumen in the segment contained within the balloon helium loss or blood in the helium pathway Recall start date: April 30, 2024

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

75492

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Affected products

Product 1

Affected products - UltraFLEX™ Intra-Aortic Balloon, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - IAB-06840-U IAB-06830-U

Product 2

Affected products - Ultra IABP Catheter Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - IAB-05830-U IAB-05840-U

Risk / hazard

Teleflex is initiating this voluntary correction for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: failure of the intra-aortic balloon to completely inflate over its full length damaged or broken central lumen in the segment contained within the balloon helium loss or blood in the helium pathway Recall start date: April 30, 2024

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, Ultra Intra-aortic Balloon Pumps.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

75492

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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