Reported Feb 24, 2021 · Ongoing
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs:…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 5290 California Ave · Irvine, CA · 92617-3073
Is this the product you have?
- Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves
- and Shunts for the following CFNs27739 - 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
- Lot codes and dates
- Lot numbers for the affected CFNs
353 of 353 codes
021949849202194712290218700308021949849502204239690219378043021980294702193959190219395920021939592102194713510219470063021947006402194713520219127878021912787902191278800219550965021955112602195511280219551134021912787102191278720219127873021912787402191278750219127876021948019602194801970219480199021948020002194990100219551136021955113802195511390219551140021947123702199317270218700307021926790202194712270219931726021946766002194676610219467663021720712702172071280218226186021824771602182871890218605901021860590202186090970218609100021860910102191715830219171709021935215102193521520219480334
- Lot numbers for the affected CFNs
- Amount recalled
- 22,528 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Neurosurgery recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.