Recall Z-1259-2015 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International Inc
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
| Date | Mar 10, 2015 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere. |
| Root cause | Process control |
| Action | Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned. |
| Quantity | 166 units |
| Distribution | Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021462 | ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 Arrow Intl., Inc., Jun 6, 2002 |