Reported Feb 24, 2021 · Ongoing
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048…
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 Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves
- for the following CFNs/REF numbers24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-5 - VALVE 27219-5 DELTA NEONATE 1.5 IMP, 27554-1 - VALVE 27554-1 DELTA SM EXTRACTED PL 1.0, 27554-2 - VALVE 27554-2 DELTA SM EXTRACTED PL 2.0, 27554-5 - VALVE 27554-5 DELTA SM EXTRACTED PL 1.5, 42812 - VALVE 42812 DELTA SMALL LEVEL I, 42813 - VALVE 42813 DELTA SMALL LEVEL 1.5, 42814 - VALVE 42814 DELTA SMALL LEVEL II, 42822 - VALVE 42822 DELTA REG PRESS LEVEL I IMP, 42823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5, 42824 - VALVE 42824 DELTA REG PRESS LEVEL II IMP, 46812 - ASSY 46812 DELTA SHUNT SMALL PL 1, 46813 - ASSY 46813 DELTA SHUNT SM LEV 1.5, 46822 - ASSY 46822 DELTA SHUNT REG P/L 1, 46823 - ASSY 46823 DELTA SHUNT REG LEV 1.5, 46824 - ASSY 46824 DELTA SHUNT REG P/L 2, 46832 - SHUNT 46832 NEONATAL DELTA SNAP L 1, 46833 - SHUNT 46833 NEONATAL DELTA SNAP 1.5, 46834 - SHUNT 46834 NEONATAL DELTA SNAP L 2, 92822 - VALVE 92822 BIOGLIDE DELTA REG. 1.0, 92823 - VALVE 92823 BIOGLIDE DELTA REG. 1.5
- Lot codes and dates
- Lot numbers for the affected CFNs
98 of 98 codes
021879659602201739930220631950021880695902193546420220201977021940490002194049020219501288021950128902198698170219278742021927874302192787440219698794021980917102199488900220112694022018048602202173870220262088022039774202203977440219272923022027950102192787410219927059022014961402203932370219281777021994889302201668700220236215022072001502202853340220285335022028533602171352940218720240021872024102189928420219621242022025104602171352930218720605021872146602187214670218721468021899282602189928270219154178021928903902192890400219312362021976109102171352980218720604021928424902192842500219761089
- Lot numbers for the affected CFNs
- Amount recalled
- 2911 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.
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