Device product
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Z-1017-2022
Product summary
- Event
- Event 89882
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units (OUS)
- Official record key
device-enforcement:Z-1017-2022
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: PD02, PD00013142 UDI: 00802526618000
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