SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 606 units of the Sherpa NX Active Guiding Catheter, 6F JL4.0 SH model (.070" diameter), a device used in cardiovascular procedures. The recalled devices were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom. The devices are identified by GTIN 00613994822123 and include all lot and serial numbers of this product.
The recall was initiated because a subset of the 6F Sherpa catheters has a potential defect where the primary segment material may be extensively lost, which could expose underlying stainless-steel braid wires. The recall record does not specify a remedy or corrective action for affected consumers.
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: 406 units Lot/code info: GTIN: 00613994822123 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.