CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Medtronic Delta Shunt Assembly Kit with Bioglide Small recalled
Medtronic Neurosurgery is recalling Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 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-0398-2014
- FDA event ID
- 66882
- Recalling firm
- Medtronic Neurosurgery, Goleta, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 26 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 26 Nov 2013 | Classified by FDA | +8 days |
| 4 Dec 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
Where it was distributed
Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: D01859; D11969; D15985; D25462; D37523; D42401.
Where was it sold?
Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, 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 66882| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic Strata II Shunt Assembly Kit, Small recalled | Medtronic Neurosurgery | Other | Nationwide | |
| CLASS II | CSF-Unitized Shunt, Contoured Regular, Low Pressure recalled | Medtronic Neurosurgery | Other | Nationwide |
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