Recalls / —
—#184534
Product
IceSeed" 1.5 90 Cryoablation Needle
- FDA product code
- GEH — Unit, Cryosurgical, Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K060144
- Affected lot / code info
- UPN: FPRPR3202 UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235 Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284
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 #184534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.