Device product

IceRod" 1.5 90¿ Cryoablation Needle

Z-0668-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 93 units
Official record key: device-enforcement:Z-0668-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3204 UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242 Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.