Medtronic recalls specific Ares Antibiotic-Impregnated Catheters (REF 95001) 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 the risk of post-surgery infections. This affects patients who have received these catheters as part of a shunt system.
The catheter's outer pouch seal may have a defect that compromises sterility. If the pouch is not sterile, it could lead to post-operative infections requiring additional medical treatment after hydrocephalus surgery.
Patients who have received the recalled catheters as part of a shunt system for hydrocephalus treatment are most at risk. The recall applies to specific lot numbers manufactured between 2010 and 2020.
Check the lot number on the catheter packaging. The recalled items have specific lot numbers listed in the recall notice, including 0010038455 through 0010393228 and EB00006085 through EB00009476.
Look for the lot number on the catheter packaging to determine if it is in the recalled list.
The recall is due to a potential defect in the seal of the outer pouch that could compromise sterility, increasing the risk of post-operative infection after hydrocephalus surgery.
Check the lot number on the catheter packaging to see if it is in the recalled list. If it is, contact Medtronic for further instructions.
The recalled catheters have specific lot numbers listed in the recall notice, including 0010038455 through 0010393228 and EB00006085 through EB00009476.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0740-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0740-2021 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.
