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Recall Observatory FDA recall evidence

Device product

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

Z-2110-2023

June 12, 2023

Class I

Product summary

Firm
Abbott
Event
Event 92502
Status
Ongoing
Classification
Class I
Quantity
675 units
Official record key
device-enforcement:Z-2110-2023

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.