Z-2110-2023Class I

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

Name: Z-2110-2023 Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac)
Creator: Abbott
Published: 2023-06-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-06-12 / Open, Classified / root cause: design

FDA source

Abbott began a recall of Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac) on 2023-06-12. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2110-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-06-12
Posted: 2023-07-11
Recalling firm: Abbott Medical
Product: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 675 units
Distribution: Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Product codes and lots: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2110-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-11

Product code DQY

K220340Class IIAmplatzer Steerable Delivery SheathAbbott Medical / cleared 2022-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)