Recall Z-1116-2021— Medtronic Neurosurgery

Name: FDA recall Z-1116-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-11

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2021-01-11. It names 5 FDA 510(k) clearances: K123524, K083076, K060681 and 2 more. Product: Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,. Reason: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus.

Recalling firm: Medtronic Neurosurgery
Classification: Class II
Status: Ongoing
Initiated: 2021-01-11
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMMedtronic Neurosurgery·cleared 2013-02-13
K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836Medtronic Neurosurgery·cleared 2008-11-20
K060681 — MEDTRONIC PS MEDICAL STRATA TYPE VALUEMedtronic Neurosurgery·cleared 2006-09-15
K042465 — PS MEDICAL STRATA II VALVEMedtronic Neurosurgery·cleared 2004-10-19
K033850 — MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDEMedtronic Neurosurgery·cleared 2004-01-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.