Recalls / —

—#184533

Product

IceSphere" 1.5 Cryoablation Needle

FDA product code

GEH — Unit, Cryosurgical, Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K060390

Affected lot / code info

UPN: FPRPR3258   UDI: 07290104830211  Batch Number: A0125

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 #184533. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.