Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valv

FDA device recall Z-1121-2017 · posted 2017-02-02 · Terminated

Recall details

Recalling firm: Medtronic Neurosurgery
Reason for recall: 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.
Action taken: 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..
Root cause: Other
Status: Terminated
Product code: JXG
Quantity affected: 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
Date initiated: 2017-01-17
Date posted: 2017-02-02
Date terminated: 2017-06-02
Location: Goleta, CA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 (K082127)	Medtronic Neurosurgery	2008-08-27
MEDTRONIC PS MEDICAL STRATA TYPE VALUE (K060681)	Medtronic Neurosurgery	2006-09-15
PS MEDICAL STRATA II VALVE (K042465)	Medtronic Neurosurgery	2004-10-19
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE (K033850)	Medtronic Neurosurgery	2004-01-13