Amplatzer Steerable Delivery Sheath recall
Amplatzer Steerable Delivery Sheath
Why was Amplatzer Steerable Delivery Sheath recalled?
Instructions for use were updated.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741
- Product
- Amplatzer Steerable Delivery Sheath
- Recalling firm
- Abbott
- Quantity
- 529 units
- Distribution
- OUS distribution only
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)