Amplatzer recallZ-2110-2023 · Abbott · initiated Jun 12, 2023
Open, Classified
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 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
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
FDA root cause category: Device Design
What the company is doing
Abbott issued a MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023. The notice explained the problem with the device, the risk, and requested the return of all units. Should you have questions about this issue, please contact your local Abbott Representative or Abbott Support at 1-800-544-1664 (Option 2) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.
Recall details
- Recall number
- Z-2110-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2023
- Posted by the FDA
- Jul 11, 2023
- Recalling firm
- Abbott
- Quantity
- 675 units
- Product code
- DQY
- FDA submissions
- K220340
- Distribution
- Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Product description
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Code information (models, lots, serial numbers)
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Amplatzer™ ASDS-14F-075St. Jude Medical, Inc. · Catheter, percutaneous1 recall1 death35 reports
Product lines
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 16, 2026. Text above is shown as published by the FDA.
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