Device product
IceSphere" 1.5 Cryoablation Needle
Z-0674-2021
Product summary
- Event
- Event 86777
- Status
- Completed
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-0674-2021
Official wording
Reason: Complaint trend regarding needle shaft gas leaks.
Code information: UPN: FPRPR3258 UDI: 07290104830211 Batch Number: A0125
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Complaint trend regarding needle shaft gas leaks.