Abbott Amplatzer Steerable Delivery Sheath recall
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Why was Abbott Amplatzer Steerable Delivery Sheath 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
- Product
- Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
- Recalling firm
- Abbott
- Quantity
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
- Recall date
- July 19, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)