Ultra Intra-Aortic Balloon Pumps (IABP)
Summary
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 |
UltraFLEX™ Intra-Aortic Balloon |
More than 10 numbers, contact manufacturer. |
IAB-06840-U |
Ultra IABP Catheter Kit |
More than 10 numbers, contact manufacturer. |
IAB-05830-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
Arrow International LLC Subsidiary Of Teleflex Incorporated
3015 Carrington Mill Blvd., Morrisville, North Carolina, United States, 27560
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