Boston Scientific Corporation: Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Is my product affected?

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

• UPC 7290104831065

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

What happened

Boston Scientific Corporation is recalling 117 units of the IcePearl 2.1 CX Prostate Cryoablation Kit distributed nationwide due to a complaint trend regarding needle shaft gas leaks. The affected units are identified by UPN FPRPR3608 and multiple batch numbers ranging from U1308 to A1461.

The source document does not specify what an affected consumer 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: 117 units Lot/code info: UPN: FPRPR3608 UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065 Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461

Source

Official record: FDA (Device enforcement) ↗

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

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