Boston Scientific Corporation: IcePearl" 2.1 CX Cryoablation Needle

Is my product affected?

IcePearl" 2.1 CX Cryoablation Needle

• UPC 7290104831010

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

What happened

Boston Scientific Corporation has recalled 86 units of the IcePearl 2.1 CX Cryoablation Needle nationwide due to a complaint trend regarding needle shaft gas leaks. The affected product has UPN FPRPR3603 and was distributed across multiple batch numbers including U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, and A1249.

The source document does not specify a remedy for affected consumers or what action they should take 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: 86 units Lot/code info: UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249

Source

Official record: FDA (Device enforcement) ↗

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

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