Medtronic is recalling its 6Fr Sherpa NX Active Guide Catheter because of a risk of the outer material separating from the device resulting in detached fragments, which could result in the underlying stainless-steel braid wires being exposed. The FDA, in a statement, has deemed this to be a “Class I recall”. According to the FDA, Class I is the most serious type of recall as it indicates that the use of these devices may cause serious injuries or death.
The FDA statement reports that the 6Fr Sherpa NX Active Guide Catheter is used to access veins and arteries in the coronary and peripheral vascular systems. It adds that the catheter may be used to assist with the placement and exchange of guidewires and other interventional devices and administer drugs or fluids into blood vessels.
The device is being recalled because there is a risk that the outer material will separate from the device resulting in detached fragments. These fragments could be left inside the patient’s bloodstream and this—or the attempts made to retrieve the fractured pieces—could cause other serious adverse health consequences, such as continued blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, myocardial infarction or death. Medtronic received five customer complaints. However, no serious injuries or deaths were reported.
The recall does not affect the Medtronic Launcher Coronary Guide Catheter or other Medtronic coronary stents, balloons or implantable devices.
- 6Fr Sherpa NX Active Guide Catheters
- Model numbers: All models
- Manufacturing Dates: 10 March 2017 to 14 March 2019
- Distribution Dates: 3 April 2017 to 4 April 2019
- Devices Recalled in the USA: 106,298
- Date Initiated by Firm: 15 March 2019