SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F, MPH, 55CM, 070" (reference SA6MPHK), a medical device used in cardiovascular procedures. The recall affects 8 units that were distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, Taiwan, and the United Kingdom. The product is identified by GTIN 00613994823076, and all lot and serial numbers are included in the recall.
The reason for the recall is a potential defect in which a subset of these 6F Sherpa catheters may experience extensive loss of the primary segment material, which could expose the underlying stainless-steel braid wires. The source record does not specify a remedy or instructions for what affected consumers should do.
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: 8 units Lot/code info: GTIN: 00613994823076 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.