Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix — Class II medical device recall Z-1259-2015
Terminated recall by Arrow International Inc, reported 2015-03-18, distributed nationwide. Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphe
| Recall number | Z-1259-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2015-03-10 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2015-03-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 166 units |
| Reason classes | packaging |
| Lot numbers | KF1111796 |
| Model numbers | IAB-05840-LWS |
| Expiration dates | 2013-11-30 |
Product
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.
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-1259-2015. 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.