Medtronic recalls specific CSF flow control valves for hydrocephalus treatment due to potential variation in radiopaque marking visibility under X-rays.
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 in hydrocephalus treatment because the radiopaque markings might not be visible under X-rays. This could make it harder for doctors to adjust the valve properly during medical procedures.
The valves may have inconsistent radiopaque markings that aren't clearly visible under X-ray imaging. This could lead to difficulties in adjusting the valve pressure settings during medical procedures, potentially affecting treatment effectiveness.
Patients with hydrocephalus who use these specific Medtronic CSF flow control valves are affected. Medical professionals who have these valves in their treatment plans are at risk of potential errors during procedures.
Check for the specific CFN/REF numbers listed in the recall notice, such as 24048, 24053, 24147, and others. Also look for the lot numbers provided in the recall list.
Identify the valve model and CFN/REF number to see if it matches the recalled list.
The recall is due to potential variation in radiopaque marking visibility under radiographic imaging, which could affect valve adjustments during hydrocephalus treatment.
Check the valve's CFN/REF number against the list provided in the recall notice, or look for the specific lot numbers listed.
If your valve model and lot number are not on the recall list, no action is needed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1115-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1115-2021 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.
