Device product

IceRod" 1.5 PLUS Cryoablation Needle

Z-0667-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 255 units
Official record key: device-enforcement:Z-0667-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.