Device product

IceSeed" 1.5 Cryoablation Needle

Z-0676-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 152 units
Official record key: device-enforcement:Z-0676-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3201 UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181 Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.