Abbott: Medical Device Recall in 2023 - (Recall #: Z-2110-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

Product Classification:

Class I

Date Initiated: June 12, 2023

Date Posted: July 19, 2023

Recall Number: Z-2110-2023

Event ID: 92502

Reason for Recall:

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Status: Ongoing

Product Quantity: 675 units

Code Information:

UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated