ARROW FiberOptix Intra-Aortic Balloon Catheter Kit — Class II medical device recall Z-1233-2015
Terminated recall by Arrow International Inc, reported 2015-03-11, distributed nationwide. Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the co
| Recall number | Z-1233-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2015-02-05 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE |
| Quantity | 165 units |
| Reason classes | labeling |
| Lot numbers | 18F14M0001 |
Product
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Reason for recall
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1233-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.