SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 215 units of Sherpa NX Active Guiding Catheter, 6F, HSI, 100CM, 070" (reference number SA6HSI) distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and others. The catheters pose a potential hazard in which the primary segment material may extensively deteriorate, exposing underlying stainless-steel braid wires that could affect the device's performance during cardiovascular procedures.
The recall affects all lot and serial numbers of this device (GTIN: 00613994824172). The source document does not specify a remedy or instructions for affected consumers regarding how to proceed.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
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: 215 units Lot/code info: GTIN: 00613994824172 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.