The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1115-2021·Announced 2021-02-24

Medtronic Delta CSF Valves Recalled for Radiopaque Marking Visibility Issues

Medtronic is recalling Delta CSF flow control valves because radiopaque markings may not be clearly visible under X-ray imaging.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving a defect without reported harm.

Plain-English summary

Medtronic Neurosurgery is recalling 2,911 units of Delta CSF (Cerebro Spinal Fluid) Flow Control Valves. The recall covers various adjustable and fixed-pressure valves used in the management of hydrocephalus, including specific CFNs/REF numbers such as 24048, 24053, 24147, and others listed in the agency's documentation.

The reason for the recall is a potential for variation in the visibility of radiopaque markings under radiographic imaging. This issue may affect the ability to clearly visualize the valves during X-ray procedures. The affected products were distributed worldwide, including nationwide in the United States and in numerous international markets.

Patients who have these specific Medtronic Delta valves implanted should contact their healthcare provider for guidance. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY…
Manufacturer
Medtronic Neurosurgery
Category
Medical Device — Neurosurgery / Hydrocephalus
Hazard
Affected units
2,911

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 numbers for the affected CFNs: 0218796596
  • 0220173993
  • 0220631950
  • 0218806959
  • 0219354642
  • 0220201977
  • 0219404900
  • 0219404902
  • 0219501288
  • 0219501289
  • 0219869817
  • 0219278742
  • 0219278743
  • 0219278744
  • 0219698794
  • 0219809171
  • 0219948890
  • 0220112694
  • 0220180486
  • 0220217387

Distribution

Distributed nationwide across the United States.

The notice also names 2 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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