Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-0670-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

IceSphere" 1.5 90¿ Cryoablation Needle

Product Classification:

Class II

Date Initiated: November 18, 2020

Date Posted: December 30, 2020

Recall Number: Z-0670-2021

Event ID: 86777

Reason for Recall:

Complaint trend regarding needle shaft gas leaks.

Status: Completed

Product Quantity: 2,429 units

Code Information:

UPN: FPRPR3560 UDIs: 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945 Batch Numbers: U1454, U1455, U1456, U1420, U1421, U1325, U1326, U1328, U1327, U0435, U0432, U0369, U0351, U0352, T0403, T0402, T0395, T0394, T0305, T0146, T0126, T0006, T0023, T0024, T0018, T0015, A7205, A6966, A6967, A6969, A6968, A6943, A6942, A6917, A6918, A2089, A2090, A1858, A1857, A1848, A1847, A1823, A1824, A1819, A1818, A1811, A1812, A1801, A1802, A1794, A1793, A1785, A1786, A1601, A1602, A1591, A1592, A1489, A1490, A1477, A1478, A1309, A1308, A1294, A1295, A1293, A1292, A1265, A1264, A1250, A1251, A1242, A1241

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated