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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