SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 33 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070" (Reference SA6SAL75) that were distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, and others. The recalled catheters have a potential defect where the primary segment material may be extensively lost, which could expose underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product (GTIN: 00613994822871). The source document does not specify what actions affected consumers or healthcare facilities should take in response to 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: 33 units Lot/code info: GTIN: 00613994822871 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.