Device product

IceSeed" 1.5 MRI Cryoablation Needle

Z-0681-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 627 units
Official record key: device-enforcement:Z-0681-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3192 UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266 Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.