Abbott Vascular ACS .035 Torque Device recallZ-2791-2011 · Abbott Vascular · initiated Jan 7, 2011
Terminated All recalls posted in July 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Vascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
FDA root cause category: Process control
What the company is doing
Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product
Recall details
- Recall number
- Z-2791-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 7, 2011
- Posted by the FDA
- Jul 12, 2011
- Recalling firm
- Abbott Vascular
- Quantity
- 389 units total
- Product code
- DQX
- FDA submissions
- K950752
- Distribution
- Nationwide distribution, and Ireland.
Product description
Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.
Code information (models, lots, serial numbers)
Lot Number: 0121091
Other devices under the same FDA submission
3 devices cleared under K950752 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ACCESSORIES 1003330Abbott Vascular Inc. · WIRE, GUIDE, CATHETER72 reports
- ACCESSORIES 22295-115Abbott Vascular Inc. · WIRE, GUIDE, CATHETER6 reports
- ACCESSORIES 22295Abbott Vascular Inc. · WIRE, GUIDE, CATHETER4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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