Abbott: Medical Device Recall in 2022 - (Recall #: Z-0895-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Amplatzer Steerable Delivery Sheath

Product Classification:

Class II

Date Initiated: November 9, 2021

Date Posted: April 13, 2022

Recall Number: Z-0895-2022

Event ID: 89714

Reason for Recall:

Instructions for use were updated.

Status: Terminated

Product Quantity: 529 units

Code Information:

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

Distribution Pattern:

OUS distribution only

Voluntary or Mandated:

Voluntary: Firm initiated