CLASS II ONGOING Device recall · Reported 23 Aug 2023 · FDA Enforcement Report
Medtronic REF 46915 Duet External Drainage and Monitoring system recalled
Medtronic Neurosurgery is recalling Medtronic REF 46915 Duet External Drainage and Monitoring system, distributed nationwide in the US. The recall was initiated on 28 Jun 2023 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-2412-2023
- FDA event ID
- 92702
- Recalling firm
- Medtronic Neurosurgery, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jun 2023
- FDA classified
- 17 Aug 2023
- Reported
- 23 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 28 Jun 2023 | Recall initiated by company | |
| 17 Aug 2023 | Classified by FDA | +50 days |
| 23 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeling contains incorrect expiration date
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Where it was distributed
US Nationwide distribution in the states of NJ, FL, CA, IL.
Questions about this recall
Is Medtronic REF 46915 Duet External Drainage and Monitoring system recalled?
Yes. Medtronic Neurosurgery recalled Medtronic REF 46915 Duet External Drainage and Monitoring system on 28 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2412-2023.
Why was it recalled?
Product labeling contains incorrect expiration date
Which lots are affected?
Lot # 226632942; UDI-DI: 00763000624781
Where was it sold?
US Nationwide distribution in the states of NJ, FL, CA, IL.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Sterility | Nationwide |
| Device | CLASS I | Medtronic Duet External Drainage and Monitoring System recalled | Medtronic Neurosurgery | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |