FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
- Recall number
- Z-1259-2015
- Recalling firm
- Arrow International Inc
- Product
- Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
- Status
- Terminated
- Initiated
- 2013-11-08
- Posted
- 2015-03-10
- Terminated
- 2015-03-16
- 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.
- Lot, serial or model codes
- Lot Number: KF1111796 Exp. Date: 11/30/2013
- 510(k) numbers
- ["K021462"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28