Recalls / —

—#184545

Product

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: FPRPR3606  UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041  Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171

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 #184545. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.