Reported Jul 19, 2023 · Ongoing
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Abbott
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 5050 Nathan Ln N · Plymouth, MN · 55442-3209
Is this the product you have?
- Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
- Lot codes and dates
- UDI/DI 05415067036025
- Batch Numbers
8597228859898386016768611443861919786278778650955866367987956688815423882460788305308846835
- Amount recalled
- 675 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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