medical Class I Updated 2023-07-19

Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835
View official government recall

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