---
title: "Amplatzer Steerable Delivery Sheath — FDA record Z-0895-2022 | Is It on Recall"
description: "Instructions for use were updated."
url: https://isitonrecall.com/recall/fda-device-z-0895-2022-amplatzer-steerable-delivery-sheath/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0895-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0895-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott records](https://isitonrecall.com/brand/abbott/)