Z-2110-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- June 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 675 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Code Information
UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835