CLASS I Device recall · Reported 9 Jul 2014 · FDA Enforcement Report
Medtronic Duet External Drainage and Monitoring System recalled
Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, distributed in Puerto Rico. The recall was initiated on 9 Jun 2014 and the FDA has classified it as Class I.
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-1921-2014
- FDA event ID
- 68503
- Recalling firm
- Medtronic Neurosurgery, Goleta, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jun 2014
- FDA classified
- 27 Jun 2014
- Reported
- 9 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 9 Jun 2014 | Recall initiated by company | |
| 27 Jun 2014 | Classified by FDA | +18 days |
| 9 Jul 2014 | 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
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Product as listed by the FDA
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Where it was distributed
Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Questions about this recall
Why was it recalled?
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Which lots are affected?
Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802
Where was it sold?
Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
4 other products · FDA event 68503| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | PR | |
| CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | PR | |
| CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | PR | |
| CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Other | PR |
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 |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |