The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0873-2021·Announced 2021-01-27

Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: The recall is classified as FDA Class II, and the defect involves a structural failure of a critical medical device (shunt malfunction) that poses a significant risk of injury to patients.

Plain-English summary

Medtronic Neurosurgery is recalling specific lots of Neonatal Delta Valve Shunt Assemblies. The affected product is the REF 27219-5 X1, Medtronic Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO. These assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF 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 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, and 0220752505. The products were distributed worldwide, including nationwide in the United States and in specific countries such as Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, the Russian Federation, Serbia, South Africa, Spain, and the United Kingdom. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the replacement or removal of these devices.

The recalled product

Product
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, 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…
Manufacturer
Medtronic Neurosurgery
Category
Medical Device — Neurosurgery / Shunt Systems
Hazard

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 # 0219948893
  • 0220166870
  • 0220236215
  • 0220704352
  • 0220720015
  • 0220752505

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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.

See all 3 products in this recall →

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