IceSphere" 1.5 CX 90¿ Cryoablation Needle recall
IceSphere" 1.5 CX 90¿ Cryoablation Needle
Why was IceSphere" 1.5 CX 90¿ Cryoablation Needle recalled?
Complaint trend regarding needle shaft gas leaks.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN: FPRPR3573 UDIs: 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133 Batch Numbers: U1458, U1457, U1459, U1460, U1461, U1429, U1428, U1426, U1427, U1425, U1430, U1333, U1331, U1232, U1230, U1334, U1332, U1335, U1330, U1229, U1231, U1222, U1221, U1219, U1220, U1184, U1182, U1180, U1179, U1183, U1181, U1162, U1161, U1160, U0982, U0981, U0977, U0980, U0922, U0923, U0920, U0921, U0872, U0870, U0871, U0873, U0519, U0518, U0508, U0303, U0300, U0301, U0302, U0472, U0299, U0298, U0262, U0260, U0259, U0257, U0258, U0261, U0239, U0240, U0219, X0230, U0220, U0207, U0193, U0184, U0168, U0169, U0167, U0125, U0124, U0126, U0127, U0128, U0099, U0098, U0058, U0059, U0057, U0052, U0051, U0018, U0017, T0802, T0828, T0829, T0803, T0820, T0798, T0800, T0799, T0780, T0704, T0694, T0695, T0703, T0682, T0683, T0671, T0670, T0655, T0656, T0658, T0657, T0653, T0654, T0593, T0594, T0583, T0584, T0577, T0578, T0567, T0458, T0455, T0456, T0379, T0378, T0366, T0367, T0350, T0349, T0326, T0327, T0308, T0307, T0301, T0302, T0205, T0204, T0102, T0101, T0093, T0094, T0080, T0081, T0072, T0073, A7127, A7126, A7117, A7118, A7104, A7103, A7079, A7078, A6998, A6999, X6978, A6965, A6964, A6949, A6948, A6932, A6933, A6870, A6871, A6860, A6861, A6854, A6855, A6786, A6785, A6767, A6768, A6756, A6755, A6745, A6746, A6691, A6690, A6680, A6679, A6670, A6669, A6642, A6643, A6632, A6633, A1977, A1976, A1973, A1974, A1966, A1967, A1780, A1779, A1762, A1763, A1465, A1466, A1443, A1442, A1428, A1427, A1395, A1396, A1275, A1274, A1181, A1182
- Product
- IceSphere" 1.5 CX 90¿ Cryoablation Needle
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 6,363 units
- Distribution
- Nationwide
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)