Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Reported: March 18, 2015 Initiated: November 8, 2013 #Z-1259-2015
Product Description
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Reason for Recall
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 166 units
- Distribution
- Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS. Recalled by Arrow International Inc. Units affected: 166 units.
Why was this product recalled? ▼
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2015. Severity: Moderate. Recall number: Z-1259-2015.
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