SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 22 units of the SHERPA NX ACTIVE GUIDING CATHETER (6F, JL4.0, 110CM, 070", REF SA6JL40A) used in cardiovascular procedures. The devices have a potential defect where the outer material may extensively deteriorate and expose the underlying stainless-steel braid wires underneath. The affected catheters were distributed worldwide to customers in the United States and 24 other countries.
The recall notice 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: 22 units Lot/code info: GTIN: 00613994822185 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.