Reported Apr 19, 2017 · Terminated
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow…
Medtronic Neurosurgery
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 125 Cremona Dr · Goleta, CA · 93117-3083
Is this the product you have?
- The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide
- the full range of performance levels0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing
- Lot codes and dates
63 of 63 codes
Worldwide Catalog Number 42955VALVE 42955 FP-STRATAMR SMALL E03581E04352E05120E05121E06139E06476E09475E11656E12556E12753E13482E13483E13484E13641E14518E14519E18555E18556E18557E18558E19670E19866 Catalog Number 42965VALVE 42965 FP-STRATAMR REGULAR E03582E04353E06015E06016E06138E06412E09619E11655E12041E12265E12266E12950E12951E12952E12953E13485E13698E18559E18560E19084E19540E19671E19867E22208E22242 Catalog Number 46955ASSY 46955 FP SHUNT STRATAMR SMALL E12752E12932E13573E16247 Catalog Number 46960SHUNT 46960 SNAP STRATAMR SMALL E12273E12780E12934E14748 Catalog Number 46965ASSY 46965 FP SHUNT STRATAMR REGULAR E12779E12933E13576E14270 Catalog Number 46970
- Amount recalled
- 2622 units (US = 1796, outside US =826)
Why it was recalled
Stop using this product now
Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.
Using this product could cause serious injury, illness or death — stop using it now.
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