SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. 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 SL3.0, .070" (REF SA6SL30), a cardiovascular device. The recall affects 3 units that were distributed worldwide to countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, and others. The problem is that a subset of these 6F Sherpa catheters has the potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires.
The recall notice does not specify a remedy or corrective action that affected consumers should take.
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: 3 units Lot/code info: GTIN: 00613994822543 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.