Device product

IceRod" 1.5 MRI Cryoablation Needle¿

Z-0679-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 772 units
Official record key: device-enforcement:Z-0679-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273 Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.