CLASS II ONGOING Device recall · Reported 27 Jan 2021 · FDA Enforcement Report
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level recalled
Medtronic Neurosurgery is recalling REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level, distributed nationwide in the US. The recall was initiated on 16 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0872-2021
- FDA event ID
- 87069
- Recalling firm
- Medtronic Neurosurgery, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2020
- FDA classified
- 15 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2020 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +30 days |
| 27 Jan 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMichiganMissouriNorth DakotaNew MexicoNevadaNew YorkOhioOklahomaTennessee
Questions about this recall
Why was it recalled?
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Which lots are affected?
Lot # 0219281777
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87069| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level recalled | Medtronic Neurosurgery | Device Malfunction | Nationwide | |
| CLASS II | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level recalled | Medtronic Neurosurgery | Device Malfunction | Nationwide |
More recalls from Medtronic Neurosurgery
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ventriculostomy Kit recalled by Medtronic Neurosurgery | Medtronic Neurosurgery | Other | Nationwide |
| Device | CLASS I | Becker External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Packaging Defects | Nationwide |
| Device | CLASS I | Exacta External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Packaging Defects | Nationwide |
| Device | CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | Nationwide |
| Device | CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |