Boston Scientific Corporation: IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Is my product affected?

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

• UPC 7290104830594

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

What happened

Boston Scientific Corporation is recalling 525 units of the IceEDGE 2.4 90° Cryoablation Needle due to a complaint trend regarding gas leaks in the needle shaft. The affected product was distributed nationwide and is identified by UPN FPRPR3506. The recalled units are associated with multiple batch numbers, including U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, and A1374.

The source document does not specify a remedy or recommend actions for affected consumers to 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: 525 units Lot/code info: UPN: FPRPR3506 UDIs: 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594 Batch Numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374

Source

Official record: FDA (Device enforcement) ↗

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

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