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Open, Classified

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

FDA Recall Z-2110-2023 · Posted 2023-07-11

Recalling FirmAbbott
Recall StatusOpen, Classified
Product CodeDQY
Date Initiated2023-06-12
Product Quantity675 units

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.

Firm Action

Abbott issued a MEDICAL DEVICE RECALL notice to its consignees beginning on 06/12/2023. The notice explained the problem with the device, the risk, and requested the return of all units. Should you have questions about this issue, please contact your local Abbott Representative or Abbott Support at 1-800-544-1664 (Option 2) (U.S.), 7:00 a.m. - 7:00 p.m. Central Time, Monday through Friday.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220340Amplatzer Steerable Delivery SheathABBOTT MEDICAL · 2022-03-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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