Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity of 4. Although no injuries or deaths have been reported, the potential for catheter disconnection in a device critical for managing intracranial pressure represents a serious functional failure with potential for patient harm.
Plain-English summary
Medtronic Neurosurgery is recalling 11,840 units of its Duet External Drainage and Monitoring System (REF 46916), which includes SmartSite Injection Sites and a Ventricular Catheter. The device is used in healthcare settings to drain cerebrospinal fluid and reduce intracranial pressure in patients.
The recalled devices have a potential defect in which the catheter may disconnect from the patient line stopcock connectors. If disconnection occurs, the device may fail to function as intended.
The affected devices were distributed worldwide, including all U.S. states, Puerto Rico, and many countries internationally. Hospitals, surgical centers, and other medical facilities may have been supplied with affected units based on the distributed lot numbers.
Healthcare facilities and professionals should identify potentially affected devices using the provided lot numbers and contact Medtronic for guidance on device replacement or return. The FDA and Medtronic are overseeing this recall.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Manufacturer
- Medtronic Neurosurgery
- Affected units
- 11,840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Number/GTIN: 221343119 00613994445391
- 221612695 00613994445391
- 221873429 00613994445391
- 221873431 00763000406011
- 222082062 00613994445391
- 222480771 00763000406011
- 222480772 00763000406011
- 223565026 00763000624798
- 223580361 00763000624798
- 223580378 00763000624798
- 223618474 00763000624798
- 223621056 00763000624798
- 223659561 00763000624798
- 223907224 00613994445391
- 223907225 00613994445391
- 223956150 00613994445391
- 223999042 00613994445391
- 223999043 00613994445391
- 224032609 00613994445391
- 224128508 00763000406011
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Medtronic Neurosurgery
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FDA (Devices) · 2026-07-29
- SevereMedtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
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- SevereExacta External Drainage System Stopcocks May Leak or Crack
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- SevereMedtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
FDA (Devices) · 2024-03-06
Same hazard · catheter disconnection
See all →- SevereMedtronic Duet External Drainage System catheter disconnection risk recalled
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
FDA (Devices) · 2024-03-06
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