FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054. Intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
- Recall number
- Z-1634-2008
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054. Intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
- Status
- Terminated
- Initiated
- 2008-03-17
- Posted
- 2008-08-13
- Terminated
- 2011-07-07
- Reason
- Mislabeling: The part number on the product label packaging may not match the product.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.
- Quantity
- 7 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Number: 8011791
- 510(k) numbers
- ["K972484"]
- PMA numbers
- not on file
- Product code
- DQY
- 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