SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 57 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070" (REF SA6JR60) used in cardiovascular procedures. The devices were distributed worldwide to the US and 24 other countries. The recall was issued because there is a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters.
The recall notice does not specify a remedy for affected consumers.
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: 57 units Lot/code info: GTIN: 00613994821782 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.