COAPTIUM Connect devices with model NCOCO1510 have a revised shelf life from 36 to 26 months to prevent perioperative breakage during surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
COAPTIUM Connect devices with model NCOCO1510 have a reduced shelf life from 36 to 26 months. Using them beyond this period risks device breakage during surgery, potentially requiring revision surgery.
The device may break during surgery if used beyond its validated shelf life, which could require additional surgery to fix the issue. This risk is tied to the device's age, not typical use conditions.
Medical professionals using COAPTIUM Connect devices for nerve repair surgery. Patients undergoing procedures with these devices are at risk if the device is used past its 26-month shelf life.
Check for model number NCOCO1510 on the device. Devices sold with lot numbers 250700041 or 25100032 are affected.
Verify the device's current shelf life label; if it shows 36 months, it is affected and needs relabeling to 26 months.
The manufacturer found that the original 36-month shelf life wasn't supported by real-time data, so they revised it to 26 months to ensure device safety.
The device may break during surgery, requiring revision surgery to fix the issue.
No action is needed; the device is safe to use within its updated 26-month shelf life.
We’ve drafted a message you can send COAPTIUM Connect to request your refund or repair — edit it as you like.
Subject: Recall Z-2901-2026 — COAPTIUM Connect COAPTIUM Connect Hello, I own a COAPTIUM Connect that is covered by recall Z-2901-2026 from COAPTIUM Connect. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
