SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070", REF SA6SAL10. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled 191 units of Sherpa NX Active Guiding Catheter, 6F SAL1.0, .070" (Reference SA6SAL10) used in cardiovascular procedures. The recalled devices were distributed worldwide, including to the United States and 24 other countries. The catheter has a potential defect where the outer material layer may wear away extensively, which could expose underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product model. The product identification number is GTIN 00613994823199. 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: 191 units Lot/code info: GTIN: 00613994823199 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.