Recalls / —
—#184530
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
- K141485
- Affected lot / code info
- UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185
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 #184530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.