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IceSphere" 1.5 CX 90 Cryoablation Needle recallZ-0664-2021 · Boston Scientific Corporation · initiated Nov 18, 2020

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaint trend regarding needle shaft gas leaks.

FDA root cause category: Under Investigation by firm

What the company is doing

Customers will be sent a product advisory via overnight mail.

Recall details

Recall number
Z-0664-2021
Status
Completed
Initiated by the company
Nov 18, 2020
Recalling firm
Boston Scientific Corporation
Quantity
6,363 units
Product code
GEH
FDA submissions
K181741
Distribution
Nationwide

Product description

IceSphere" 1.5 CX 90 Cryoablation Needle

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 86777).

Sources and updates

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