Medtronic Vascular: SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use

Is my product affected?

SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use

• UPC 00613994823809

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

What happened

Medtronic is recalling 609 units of Sherpa NX Active Guiding Catheter (6F 3DRIGHT, .070", REF SA63DRIGHT) distributed worldwide. The catheters pose a potential hazard in which the outer material may extensively deteriorate, exposing underlying stainless-steel braid wires that could cause patient injury during cardiovascular procedures.

The recall affects units with GTIN 00613994823809 across all lot and serial numbers. The source document does not specify what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

Details from the source

Reason for recall: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. Distribution: Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom Quantity: 409 units Lot/code info: GTIN: 00613994823809 All Lot/Serial Numbers

Source

Official record: FDA (Device enforcement) ↗

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

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