Recall Z-1121-2017 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Va
| Date | Feb 2, 2017 (initiated Jan 17, 2017) |
| Status | Terminated |
| Reason | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image. |
| Root cause | Other |
| Action | Medtronic sent an Urgent Product Advisory Notice dated January 19, 2017, was sent to customers to inform them that Medtronic Neurosurgery is initiating a voluntary field corrective action (FCA) for the Medtronic Strata II / Strata NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR). Medtronic is notifying healthcare providers of an Instructions For Use (IFU) Warning update for the affected products by sending a Product Advisory Notice. For further questions regarding this recall please call (805) 571-8400.. |
| Quantity | 315,997 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Fede |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033850 | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE Medtronic Neurosurgery, Jan 13, 2004 |
| K042465 | PS MEDICAL STRATA II VALVE Medtronic Neurosurgery, Oct 19, 2004 |
| K060681 | MEDTRONIC PS MEDICAL STRATA TYPE VALUE Medtronic Neurosurgery, Sep 15, 2006 |
| K082127 | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 Medtronic Neurosurgery, Aug 27, 2008 |