Boston Scientific Corporation: IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

Is my product affected?

IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

• UPC 7290104831089

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling 740 units of the IceFORCE 2.1 CX L 90° Cryoablation Needle nationwide due to a complaint trend regarding gas leaks in the needle shaft. The affected product has UPN FPRPR3618 and multiple batch numbers ranging from A1188 to U1215, with the UDI 7290104831089.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaint trend regarding needle shaft gas leaks.

Details from the source

Reason for recall: Complaint trend regarding needle shaft gas leaks. Distribution: Nationwide Quantity: 740 units Lot/code info: UPN: FPRPR3618 UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089 Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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