Medtronic Vascular: SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use

Is my product affected?

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use

• UPC 00613994821706

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

What happened

Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheter (6F LCB 90CM, .070", REF SA6LCBD) distributed worldwide. The recalled catheters have a potential defect where the outer material layer may extensively deteriorate, exposing the underlying stainless-steel braid wires. This catheter is used in cardiovascular procedures.

The recall affects all lot and serial numbers of this product (GTIN: 00613994821706). The source does not specify a remedy or describe 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: 3 units Lot/code info: GTIN: 00613994821706 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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