Boston Scientific Corporation: IceRod" 1.5 PLUS Cryoablation Needle

Is my product affected?

IceRod" 1.5 PLUS Cryoablation Needle

• UPC 7290104830570

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

What happened

Boston Scientific Corporation is recalling 255 units of the IceRod 1.5 PLUS Cryoablation Needle due to a complaint trend regarding gas leaks in the needle shaft. The affected product was distributed nationwide and includes specific lot and batch numbers (U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, and A1531).

The recall record does not specify a remedy or instructions for affected consumers regarding what action they should take.

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: 255 units Lot/code info: UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531

Source

Official record: FDA (Device enforcement) ↗

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

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