FDA Device Recalls

Recalls / —

—#184537

Product

IceRod" 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: FPRPR3195  UDIs: 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297  Batch Numbers: U1406, U1407, U1370, U1369, U1041, U1042, U0611, U0610, U0501, U0419, U0447, U0444, U0418, U0322, U0323, U0211, U0243, U0244, U0208, U0209, U0210, U0189, U0188, U0175, U0174, U0031, U0164, U0005, U0004, U0002, U0001, T0786, T0785, T0664, T0665, T0649, T0650, T0562, T0561, T0452, T0451, T0445, T0441, T0440, T0364, T0365, T0361, T0360, T0192, T0193, T0179, T0180, A7213, A6715, A6714, A6712, A6711, A6672, A6673, A2093, A2094, A2036, A2037, A2023, A2024, A2011, A2012, A1986, A1987, A1949, A1948, A1944, A1943, A1925, A1924, A1884, A1883, A1839, A1837, A1838, A1832, A1833, A1758, A1759, A1756, A1757, A1648, A1647, A1572, A1573, A1555, A1556, A1534, A1334, A1321, A1322, A1318, A1319, A1200, A1198, A1201, A1199, A1070, A1071, A1068, A1067, A1002, A1001, A0882, A0883, A0878, A0879, A0737, A0738

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 #184537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.