SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled the SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070" (Reference SA6ELGAMALSH), a device used in cardiovascular procedures. The recall affects 6 units worldwide and involves a potential defect where the outer material of the primary segment may be lost extensively, which could expose underlying stainless-steel braid wires. The affected devices carry GTIN 00613994824776 and all lot and serial numbers of this product are included in the recall. The devices were distributed to hospitals and medical facilities in the United States, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Africa, Slovakia, South Africa, Spain, Sweden, Taiwan, and the United Kingdom.
The recall record does not specify a remedy or instructions for affected consumers or healthcare providers regarding what actions should be taken with recalled units.
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: 6 units Lot/code info: GTIN: 00613994824776 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.