SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 8,966 units of Sherpa NX Active Guiding Catheter, 6F JL4.0, .070" (model SA6JL40) distributed worldwide. The catheters are used in cardiovascular procedures. The recall was initiated because some units in this product line have the potential to lose extensive amounts of their primary segment material, which could expose the underlying stainless-steel braid wires.
The affected catheters were distributed to hospitals and medical facilities in the United States and 24 other countries, including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, the United Kingdom, and others. The recall covers all lot and serial numbers of this model. The source document does not specify what actions affected consumers 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: 8966 units Lot/code info: GTIN: 00613994822208 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.