Z-0895-2022Class II

Amplatzer Steerable Delivery Sheath

Name: Z-0895-2022 Amplatzer Steerable Delivery Sheath
Creator: Abbott
Published: 2021-11-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-11-09 / Terminated / root cause: design

FDA source

Abbott began a recall of Amplatzer Steerable Delivery Sheath on 2021-11-09. FDA classified it as Class II and gives the reason as "Instructions for use were updated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0895-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-09
Posted: 2022-04-07
Terminated: 2024-08-07
Recalling firm: Abbott Medical
Product: Amplatzer Steerable Delivery Sheath
Product code: DQY Catheter, Percutaneous
Reason for recall: Instructions for use were updated.
Root cause tag: design
FDA 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 in commerce: 529 units
Distribution: OUS distribution only
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0895-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0895-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code DQY

K212026Class IIAmplatzer Steerable Delivery SheathAbbott Medical / cleared 2021-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)