Device product

IceSphere" 1.5 S 90¿ Cryoablation Needle

Z-0672-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 729 units
Official record key: device-enforcement:Z-0672-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3561 UDIs: 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556 Batch Numbers: U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.