Medtronic recalls Duet External Drainage System with potential catheter disconnection from patient line stopcock connectors. Affected units have specific lot numbers.
Potential for catheter disconnection from the patient line stopcock connectors.
Medtronic is recalling its Duet External Drainage and Monitoring System due to a risk of catheter disconnection from patient line stopcock connectors. This could lead to improper drainage of cerebrospinal fluid and potential complications for patients.
The device has a potential for catheter disconnection at the patient line stopcock connectors. This could cause improper drainage of cerebrospinal fluid, leading to increased intracranial pressure or other complications.
Patients using this medical device for cerebrospinal fluid drainage are affected. Those with specific lot numbers listed in the recall are most at risk.
Check for lot numbers starting with 221482527, 221569956, 221569957, or other numbers listed in the recall. The product is used for draining cerebrospinal fluid to reduce pressure.
Look for the lot number on the device packaging or label, which starts with specific numbers listed in the recall.
The recall is due to a potential for catheter disconnection from patient line stopcock connectors, which could lead to improper drainage of cerebrospinal fluid.
Check your device's lot number against the list provided in the recall. If it matches, contact Medtronic for further instructions.
The recall states a potential for catheter disconnection, but does not specify that it can cause death or serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1162-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1162-2024 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.