SHERPA NX ACTIVE GUIDING CATHETER, 6F JR5.0 SH, .070", REF SA6JR50SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 105 units of the Sherpa NX Active Guiding Catheter, 6F JR5.0 SH model (.070") used in cardiovascular procedures. The devices were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, and others. The recall was initiated because a subset of these 6F Sherpa catheters has the potential to lose extensive amounts of primary segment material, which could expose the underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product (GTIN: 00613994821799). The recall record does not specify a remedy or what consumers should do if they have received or used this product.
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: 105 units Lot/code info: GTIN: 00613994821799 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.