Amplatzer Steerable Delivery Sheath
- Company
- Abbott
- Recall Initiated
- November 9, 2021
- Terminated
- August 7, 2024
- Recall Number
- Z-0895-2022
- Quantity
- 529 units
- Firm Location
- Plymouth, MN
Reason for Recall
Instructions for use were updated.
Distribution
OUS distribution only
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.
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