Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1117-2021·Announced 2021-02-24

Medtronic CSF-Flow Control Valves Recalled for Radiopaque Marking Visibility Issues

Medtronic Neurosurgery is recalling 20,817 CSF-Flow Control Valves worldwide due to potential variation in radiopaque marking visibility under radiographic 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. The hazard is a potential variation in radiopaque marking visibility, which is a diagnostic/monitoring issue rather than a direct structural failure or reported injury, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls without reported harm.

Plain-English summary

Medtronic Neurosurgery is recalling 20,817 units of Cerebro Spinal Fluid (CSF)-Flow Control Valves, including adjustable and fixed-pressure models used in the management of hydrocephalus. The recall is due to a potential for variation in the visibility of radiopaque markings under radiographic imaging.

The affected products were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the number of patients affected or report any illnesses or injuries associated with this defect.

Healthcare providers and patients should consult with their medical professionals regarding the use of these devices. The recall notice does not provide specific consumer action steps beyond the identification of the affected lot numbers and catalog numbers.

The recalled product

Product: Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US…
Manufacturer: Medtronic Neurosurgery
Category: Medical Device — Neurosurgery / Hydrocephalus
Hazard: imaging-visibility
device-defect
Affected units: 20,817

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: 0219278853
0219278854
0220099072
0219278855
0219278856
0219768090
0219768091
0219798970
0219798971
0219798972
0220010048
0220112693
0220141392
0219802495
0219802494
0219583129
0220286100
0218796592
0219952709
0218806424

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 →

Same manufacturer · Medtronic Neurosurgery

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Same hazard · imaging visibility