FDA Device recall Z-1064-2013
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc by Arrow International, citing potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1064-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-27 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
Reason
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Identifiers
| code_info | Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1064-2013%22
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