Boston Scientific Corporation: IceRod" 1.5 MRI Cryoablation Needle¿

Is my product affected?

IceRod" 1.5 MRI Cryoablation Needle¿

• UPC 7290104830273

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

What happened

Boston Scientific Corporation is recalling 772 units of the IceRod 1.5 MRI Cryoablation Needle due to a complaint trend regarding gas leaks in the needle shaft. The affected devices were distributed nationwide and are identified by UPN FPRPR3193 across multiple batch numbers including U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, and A1150.

The recall notice does not specify a remedy or recommended action 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: 772 units Lot/code info: UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273 Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150

Source

Official record: FDA (Device enforcement) ↗

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

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