FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Recall number
- Z-1178-2010
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Status
- Terminated
- Initiated
- 2009-05-06
- Posted
- 2010-03-22
- Terminated
- 2012-03-30
- Reason
- Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
- Root cause
- Labeling mix-ups
- Action
- Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
- Quantity
- 26
- Distribution
- Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
- Lot, serial or model codes
- Lot Number: 8121251.
- 510(k) numbers
- K072798
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- 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