Skip to content
Recall Observatory FDA recall evidence

Device product

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Z-0685-2021

November 18, 2020

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 86777
Status
Completed
Classification
Class II
Quantity
117 units
Official record key
device-enforcement:Z-0685-2021

Official wording

Reason: Complaint trend regarding needle shaft gas leaks.

Code information: UPN: FPRPR3608 UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065 Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complaint trend regarding needle shaft gas leaks.