StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid

[Posted 04/08/2017]

AUDIENCE: Neurology, Surgery

ISSUE: Medtronic announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR adjustable valves and shunts. Medtronic is conducting this voluntary recall due to 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 consequences: headaches, nausea, vomiting and lethargy. If left untreated, under-drainage can potentially lead to coma and death.

BACKGROUND: As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

RECOMMENDATION: Patients and their caregivers should monitor the patient's condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

Medtronic is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. If any of the affected products have been implanted in patients, physicians 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.

See the Recall Notice for a sample product label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/06/2017 - Recall Notice - Medtronic]