Recalls / —

—#184546

Product

Three IceFORCE" 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: FPRPR3607  UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058  Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194

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 #184546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.