Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect
Medtronic is recalling 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. According to the rubric, an FDA Class II recall involving a structural defect that could lead to device malfunction and significant injury is rated as Severe (4).
Plain-English summary
Medtronic Neurosurgery is recalling specific Neonatal Delta Valve Shunt Assemblies, identified by Lot # 0219281777. These medical 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 affected products were distributed worldwide, including in the United States and various international markets.
The recall was initiated because the neonatal valves were manufactured with a ventricular catheter connection site that is shorter than the design specification. This defect can lead to difficulty in securing the valve to the proximal catheter. If the connection is not secure, the ventricular catheter may disconnect from the valve, resulting in shunt malfunction.
Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the replacement or management of these devices. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, 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
- Category
- Medical Device — Neurosurgery
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 (1)
- Lot # 0219281777
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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