Medtronic recalls specific Ares Antibiotic-Impregnated Catheters (REF 91101) due to potential seal defects that could compromise sterility and increase infection risk after hydrocephalus surgery.
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
Medtronic is recalling certain Ares Antibiotic-Impregnated Catheters used in hydrocephalus treatment because a seal defect might allow contamination, raising infection risks after surgery. This is serious but not an immediate danger for all users.
The catheter's outer pouch seal could be defective, allowing bacteria to enter the sterile pouch. This might lead to infection after surgery, requiring additional medical treatment.
Patients who received the recalled catheters during hydrocephalus treatment are most at risk. Healthcare providers using these catheters for shunt systems may also need to check their devices.
Check for the product name 'Medtronic Ares Antibiotic-Impregnated Catheter' with reference number 91101. The lot numbers listed in the recall include specific sequences like 0010052549 through 0010393839.
Look for the reference number 91101 on the catheter packaging or label, and verify if your lot number matches the listed numbers.
If you have the recalled catheter, reach out to your surgeon to discuss potential risks and next steps for your specific case.
The recall is due to a potential defect in the outer pouch seal that could compromise sterility, increasing the risk of post-operative infection.
The affected lot numbers range from 0010052549 to 0010393839 as listed in the recall notice.
No, but you should check if your catheter is affected and contact your doctor for guidance since the risk is not immediate but requires medical evaluation.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0738-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0738-2021 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.
