Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit — Class II medical device recall Z-1064-2013
Terminated recall by Arrow International Inc, reported 2013-04-17. Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal
| Recall number | Z-1064-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2012-11-27 |
| Classified | 2013-04-05 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2015-06-02 |
| Countries outside the US | BE, GB, IT, LV, RU, SI, TR, ZA |
| Quantity | 188 units |
| Reason classes | packaging |
| Lot numbers | KF2073734, KF2083869, KF2083921, KS2083999 |
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 for recall
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
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-1064-2013. 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.