Recently, Medtronic voluntary recalled all unused units for the Medtronic Strata™ II/Strata™ NSC and StrataMR™ adjustable valves & shunts. First, don’t panic! Medtronic is not asking that any existing patients with these shunts have them removed – so, don’t fret thinking you need to have a shunt replacement! Read the quick facts below and, if you’re concerned, contact your health care provider.
StrataMR™ Valves quick facts:
- Medtronic has made the decision to physically recall StrataMR™ shunts/valves in stock at hospitals or medical facilities. The affected StrataMR™ valves and shunts were manufactured from October 27, 2015 to November 11, 2016.
- Medtronic is conducting this recall due complaints resulting from an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.
- Under-drainage of cerebrospinal fluid may result in the following adverse health implications: headaches, nausea, vomiting, and lethargy. If you or your child experience any of these symptoms, you should consult the physician who implanted the StrataMR Valve.
- Medtronic is not recommending patients with the StrataMR™ have the valve removed. If you have the StrataMR™ valve, your provider should have been given instructions for monitoring existing patients with StrataMR™ valves.
Strata™ II/Strata™ NSC Valve quick facts:
- Medtronic has initiated a Field Corrective Action (also known as a Class II recall) for Strata™ II/Strata™ NSC valves – no physical Strata™ II/Strata™ NSC valves are being recalled from the medical community.
- This recall for Strata™ II/Strata™ NSC valves involves Medtronic updating their Instructions for Use to make providers aware of a rare condition related to the Strata Valve that can lead to an inaccurate pressure (PL) reading on the Strata™ Indicator Tool or StrataVarius™ system.
- Medtronic is updating the Strata™ II/Strata™ NSC valve instructions so information relating to inaccurate pressure reading will be included in packaging for medical professionals to better monitor patients post shunt surgery.
What do you do from here?
Primarily, make sure you know what type of shunt valve(s) you have. If your shunt is programmable, ensure you know its current setting. Consider monitoring and recording your shunt settings on the Hydrocephalus Associations HydroAssist® mobile app.
Next, If the StrataMR™ Valves and shunts (NOT the Strata™ II/Strata™ NSC Valves) have been implanted in you or your child, your physician should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the Instructions for Use (IFU) for continued patient care.
Lastly, for more information on this recall or to report a problem with the recalled devices, patients and physicians can call the Medtronic hotline at 1.800.335.9557 or via email at RS.MNSFCA@medtronic.com.