Ps Medical Strata II Valve

• 2 recalls, same reason

  • Ongoing Z-1116-2021 FDA Class II ·initiated 11 Jan 2021
  • Ongoing Z-1115-2021 FDA Class II ·initiated 11 Jan 2021

  Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

• • Terminated Z-1121-2017 FDA Class II ·initiated 17 Jan 2017

  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.

• • Terminated Z-0399-2014 FDA Class II ·initiated 18 Nov 2013

  Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

510(k) Number

K042465 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• StrataMR II Valves and Shunts

  Class II

  FDA 510(k) K212641 Active Cleared 16 Sep 2021

• Medtronic Ps Medical Strata Type Value Open recall

  Class II

  FDA 510(k) K060681 Active Cleared 15 Sep 2006

• Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 and 41704-41715

  Class II

  FDA 510(k) K063836 Active Cleared 16 Aug 2007

• U-Clip Device

  Class II

  FDA 510(k) K062821 Active Cleared 19 Dec 2006

• Medtronic Strata Nsc Lumboperitoneal Valve and Shunt System Open recall

  Class II

  FDA 510(k) K123524 Active Cleared 13 Feb 2013

• Durepair Dura Regeneration Matrix

  Class II

  FDA 510(k) K041000 Active Cleared 27 Jul 2004

See all devices from Medtronic Neurosurgery →