Medtronic recalls Ares Antibiotic-Impregnated Catheters with potential seal defects that could compromise sterility, increasing 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 due to a possible seal defect that might cause infections after surgery. This recall affects patients who have received these catheters as part of their shunt system.
The catheter's outer pouch seal may have a defect that compromises sterility. This could lead to post-operative infections requiring additional medical treatment if the catheter is used in hydrocephalus surgery.
Patients who received the recalled catheters as part of their hydrocephalus shunt system are most at risk. The recall applies to specific lot numbers manufactured between 2010 and 2011.
Check the lot number on the catheter packaging. The recalled items have specific lot numbers listed in the recall notice: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, and others.
Look for the lot number on the catheter packaging to determine if it's in the list of recalled numbers.
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.
Check the lot number on the catheter packaging to see if it's in the list of recalled numbers. If it is, contact Medtronic for further instructions.
The recall indicates a potential risk, but the catheter is generally safe unless the seal defect is present. Always check the lot number.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0739-2021 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.
