Recalls / —
—#184550
Product
IceRod" Prostate Cryoablation Kit
- FDA product code
- GEH — Unit, Cryosurgical, Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K051052
- Affected lot / code info
- UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226
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 #184550. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.