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

Is my product affected?

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

• UPC 7290104831072

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

What happened

Boston Scientific Corporation is recalling 261 units of the IcePearl 2.1 CX L 90° Cryoablation Needle distributed nationwide. The recall was initiated due to a trend of complaints regarding gas leaks in the needle shaft. The affected product has UPN FPRPR3617 and multiple batch numbers ranging from A1177 to X0828.

The source document does not specify a remedy or what affected consumers should do regarding this recall.

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: 261 units Lot/code info: UPN: FPRPR3617 UDIs: 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072 Batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177

Source

Official record: FDA (Device enforcement) ↗

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

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