SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 20 units of the Sherpa NX Active Guiding Catheter (6F LCB SH, .070", REF SA6LCBSH) distributed worldwide to multiple countries including the US, Europe, Asia, and other regions. The catheter is used for cardiovascular procedures and has been identified as having a potential defect where the outer material may extensively break down, exposing underlying stainless-steel braid wires on a subset of the 6F model catheters.
The recall affects all lot and serial numbers of this product (GTIN: 00613994821690). The source document does not specify what remedy or action 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: 20 units Lot/code info: GTIN: 00613994821690 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.