Boston Scientific Corporation: IcePearl" 2.1 CX 90¿ Cryoablation Needle

Is my product affected?

IcePearl" 2.1 CX 90¿ Cryoablation Needle

• UPC 7290104830990

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

What happened

Boston Scientific Corporation has recalled 8,453 units of the IcePearl 2.1 CX 90° Cryoablation Needle nationwide. The recall was issued due to a complaint trend regarding gas leaks in the needle shaft. The affected product has UPN FPRPR3601 and multiple UDI codes (7290104830990).

The recall record does not specify a remedy or instructions for what affected consumers should do.

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: 8453 units Lot/code info: UPN: FPRPR3601 UDIs: 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 729010483

Source

Official record: FDA (Device enforcement) ↗

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

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