Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
FDA device recall Z-1259-2015 · posted 2015-03-10 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 166 units
- Distribution
- Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
- Date initiated
- 2013-11-08
- Date posted
- 2015-03-10
- Date terminated
- 2015-03-16
- Location
- Reading, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462) | Arrow Intl., Inc. | 2002-06-06 |