Recall Z-2110-2023— Abbott

Name: FDA recall Z-2110-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class I · Ongoing

Class I FDA medical device recall by Abbott, initiated 2023-06-12. It names one FDA 510(k) clearance: K220340. Product: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).. Reason: 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..

Recalling firm: Abbott
Classification: Class I
Status: Ongoing
Initiated: 2023-06-12
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K220340 — Amplatzer Steerable Delivery SheathABBOTT MEDICAL·cleared 2022-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.