Recall archive / FDA device enforcement
Amplatzer Steerable Delivery Sheath — FDA record Z-0895-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 9, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Amplatzer Steerable Delivery Sheath
- Reason
- Instructions for use were updated.
- Classification
- Class II
- Recalling firm
- Abbott
- Quantity
- 529 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0895-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OUS distribution only
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Nov 9, 2021
- Center classification date
- Apr 7, 2022
- Termination date
- Aug 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.