SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 15,603 units of the Sherpa NX Active Guiding Catheter, 6F JR4.0, .070" (REF SA6JR40) due to a potential defect affecting a subset of the 6F Sherpa catheters. The defect involves extensive loss of primary segment material that could expose underlying stainless-steel braid wires. The affected catheters were distributed worldwide, including to the United States and 24 other countries.
The source document does not specify what actions affected consumers or patients 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: 15603 units Lot/code info: GTIN:00613994822338 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.