Boston Scientific Corporation: IceRod" 1.5 PLUS 90¿ Cryoablation Needle

Is my product affected?

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

• UPC 7290104830563

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

What happened

Boston Scientific Corporation is recalling 4,645 units of the IceRod 1.5 PLUS 90° Cryoablation Needle due to a complaint trend involving gas leaks in the needle shaft. The affected product has UPN FPRPR3508 and was distributed nationwide.

The recall record does not specify a remedy or recommended action for consumers who may have this product.

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: 4,645 units Lot/code info: UPN: FPRPR3508 UDIs: 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 729010483

Source

Official record: FDA (Device enforcement) ↗

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

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