Device product

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Z-0677-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 525 units
Official record key: device-enforcement:Z-0677-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3506 UDIs: 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594 Batch Numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.