Abbott Amplatzer Steerable Delivery Sheath Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amplatzer Steerable Delivery Sheath
Brand
Abbott
Lot Codes / Batch Numbers
Model ASDS-14F-075
Products Sold
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
Abbott is recalling Amplatzer Steerable Delivery Sheath due to Instructions for use were updated.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instructions for use were updated.
Recommended Action
Per FDA guidance
Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible. The product is not being removed from the field and does not need to be returned. The recalling firm is providing additional instructions to reduce the potential for air ingress.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026