FDA recall Z-2110-2023

Product

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

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-06-12

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2023