Device product
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Z-1016-2022
Product summary
- Event
- Event 89882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units (US)
- Official record key
device-enforcement:Z-1016-2022
Official wording
Reason: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Code information: Lot Numbers: PD01, PD00013140 UDI: 00850004312001
Distribution pattern: US distribution: GA, OH Foreign distribution: Netherlands
Derived failure modes
-
Unknown
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia