Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect
Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural failure of a critical medical device component that could lead to shunt malfunction, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic Neurosurgery is recalling 95 units of the REF 27219-1 X1 Neonatal Delta Valve, Performance Level 1.0. These devices are components of CSF-Flow Control Shunt Systems designed to provide controlled cerebrospinal fluid flow from the ventricles of the brain into the peritoneal cavity.
The recall is due to a manufacturing defect where the ventricular catheter connection site was shorter than the design specification. This defect can lead to difficulty in securing the valve to the proximal catheter, which could result in the disconnection of the ventricular catheter from the valve and subsequent shunt malfunction.
The affected lots are 0219927059, 0220149614, 0220393237, 0220601648, 0220601649, and 0220813029. The devices were distributed worldwide, including nationwide in the United States and in various international locations. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the replacement or removal of these devices.
The recalled product
- Product
- REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, 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 p
- Manufacturer
- Medtronic Neurosurgery
- Affected units
- 95
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 (6)
- Lot # 0219927059
- 0220149614
- 0220393237
- 0220601648
- 0220601649
- 0220813029
Distribution
Part of a larger recall action
This product is one of 3 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.
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