Recalls / —

—#184514

Product

IceFORCE" 2.1 CX L 90 Cryoablation Needle

FDA product code

GEI — Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K162599

Affected lot / code info

UPN: FPRPR3618  UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089  Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189

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 #184514. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.