Recalls / —

—#184547

Product

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

FDA product code

GEH — Unit, Cryosurgical, Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K152133

Affected lot / code info

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

Why it was recalled

Complaint trend regarding needle shaft gas leaks.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Customers will be sent a product advisory via overnight mail.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2020-11-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184547. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.