FDA Medical Device Recalls (openFDA)
Abbott: Amplatzer Steerable Delivery Sheath
- Recall number
- Z-0895-2022
- Recalling firm
- Abbott
- Product
- Amplatzer Steerable Delivery Sheath
- Status
- Terminated
- Initiated
- 2021-11-09
- Posted
- not on file
- Terminated
- 2024-08-07
- Reason
- Instructions for use were updated.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 529 units
- Distribution
- OUS distribution only
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K212026"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28