Medtronic Addresses FDA Recall for Strata™ II/Strata™ NSC and StrataMR™ valves
Discussion on social media around the FDA notification regarding the Strata™ II/Strata™ NSC and StrataMR™ valves has led to a number of questions from patients. There are two actions currently being taken by the FDA and Medtronic to address issues with each of these products respectively.
Strata™ II/Strata™ NSC Valves
Medtronic has proactively implemented a Field Corrective Action (FCA) for its Strata™ II/Strata™ NSC valves. This type of FCA is referred to by the FDA as a ‘Class II Recall’. No actual shunt products are being “recalled” by Medtronic from the medical community. The FCA involves Medtronic updating their Instructions for Use (IFU) to make providers aware of a rare condition related to the Strata Valve that can lead to an inaccurate pressure level (PL) reading on the Strata™ Indicator Tool or StrataVarius™ system. The condition occurs only if a patient has been exposed to 3T MRI magnetic field or greater, and if biological debris is present to an extent that the valve magnet adjustment mechanism is impacted. This recall was initiated as a result of reported problems with the shunts in patients which occurred at an extremely low incident rate. Moving forward, new instructions will include this information in the packaging so medical professionals are aware as they monitor their patients after shunt surgery.
Medtronic has also made a proactive decision to physically recall StrataMR™ valves still in stock at hospitals and medical facilities. This is to address an issue where the valve pressure level may be higher than anticipated. Medtronic is not recommending patients with the StrataMR™ have the valve removed. All providers currently using the valve have been provided with instructions to monitor existing patients with StrataMR™ valves. If you have a Medtronic StrataMR™ valve, you may have already received a communication directly from your neurosurgeon or neurologist. Please follow the advice you are being sent in this letter.
Many of you are undoubtedly asking what these recalls mean to you.
First, it is important to know what type of shunt valve(s) you have and, if programmable, its current setting. We recommend recording this information in a place that is easily accessible, like our HydroAssist® mobile app or on a Patient Shunt Card you can carry in your wallet (available from your neurosurgeon or Medtronic).
Second, as is the case with most programmable shunts, your setting can change following an MRI procedure. If you are scheduled for an MRI procedure, or need to undergo an emergency procedure, always make sure that your shunt settings are checked and verified afterwards by your neurosurgeon or neurologist.
Three, if you currently have the StrataMR™ valve, be aware of any changes to how you are feeling and notify your neurosurgeon or neurologist if you have any concerns.
It is important to note that the Medtronic Delta® fixed-pressure valve and CSF-Flow Control valves are not included in this recall. The Strata™ II/Strata™ NSC valves were first made available in the U.S. beginning in February, 2002. The StrataMR™ valve was first made available in the U.S. beginning in June, 2016.
Medtronic has indicated that they will be posting a statement on these field corrective actions shortly.
Click HERE to read Medtronic’s press release.