Health product recall

Ultra Intra-Aortic Balloon Pumps (IABP)

Last updated

Summary

Product
Ultra Intra-Aortic Balloon Pumps (IABP)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalog number

Ultra 8® Intra-Aortic Balloon - Lightwave Sensor

More than 10 numbers, contact manufacturer.

IAB-05830-LWS
IAB-05840-LWS

UltraFLEX™ Intra-Aortic Balloon

More than 10 numbers, contact manufacturer.

IAB-06840-U
IAB-06830-U

Ultra IABP Catheter Kit

More than 10 numbers, contact manufacturer.

IAB-05830-U
IAB-05840-U

Issue

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

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
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-75492

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