FDA Device recall Z-1259-2015
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS by Arrow International, citing potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1259-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Reason
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Identifiers
| code_info | Lot Number: KF1111796 Exp. Date: 11/30/2013 |
|---|
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-1259-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.