Recalls / —
—#184539
Product
IceSeed" 1.5 MRI 90 Cryoablation Needle
- 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: FPRPR3194 UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280 Batch Numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954
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 #184539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.