SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 57 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070" (Reference SA6RCBSH) used in cardiovascular procedures. The recall affects all lot and serial numbers with GTIN 00613994823274 that were distributed worldwide to multiple countries including the United States, Austria, Belgium, and others. The problem involves a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters.
The record does not specify a remedy or what affected consumers should do regarding this recall.
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: 57 units Lot/code info: GTIN: 00613994823274 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.