Medtronic recalls specific CSF flow control valves for hydrocephalus treatment due to potential variation in radiopaque marking visibility under X-ray. Affected models include 22011 L, 22011 M, 22017 B, and others. No immediate action required but check if your valve matches the list.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Medtronic is recalling certain CSF flow control valves used to treat hydrocephalus because they may not show up clearly under X-ray. This could make it harder for doctors to adjust the valve properly during treatment. If you have one of the listed models, you should check the lot number and contact Medtronic.
The valves may have inconsistent radiopaque markings, which can make them harder to see clearly under X-ray. This could lead to difficulties in adjusting the valve during medical procedures, but it does not cause injury directly.
Patients with hydrocephalus who use Medtronic CSF flow control valves. The risk is low as the issue relates to X-ray visibility, not immediate harm.
Check your valve's model number and lot number against the list provided in the recall. The affected models include 22011 L, 22011 M, 22017 B, and others with specific lot numbers listed in the recall.
Look for the model number and lot number on your valve to see if it matches the list of affected items in the recall.
No, the recall does not require stopping use. The issue is about X-ray visibility, not immediate safety risks.
Compare your valve's model number and lot number with the list provided in the recall. Affected models include 22011 L, 22011 M, 2:2017 B, and others with specific lot numbers listed.
The recall does not mention any fix or remedy. Affected users should check the list and contact Medtronic for further guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1117-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1117-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.