FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
- Recall number
- Z-0749-2010
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
- Status
- Terminated
- Initiated
- 2009-10-01
- Posted
- 2010-01-29
- Terminated
- 2011-09-27
- Reason
- The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.
- Root cause
- Process control
- Action
- Abbott Vascular's Sales Representatives initiated customer contact with the identified consignees beginning October 1, 2009 . They provided the consignees with a recall letter with attached fax-back effectiveness check form. The recall letter instructed the consignees to work with their local account representative to review their inventory, complete the attached recall effectiveness check form and return identified products to Abbott Vascular. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
- Quantity
- 22 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Number: 9081851
- 510(k) numbers
- not on file
- PMA numbers
- ["P040012"]
- Product code
- NIM
- 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