Abbott recalls NC Traveler Coronary Dilatation Catheters (REF 10131:12) due to potential balloon deflation issues. This device is not cleared for US distribution.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott is recalling certain coronary dilatation catheters because they may have trouble deflating the balloon. This could cause problems during medical procedures if the catheter is used incorrectly.
The catheter's balloon may not deflate properly during use, which could lead to complications like blockages or tissue damage. This issue occurs in medical procedures where the catheter is used to open blocked blood vessels.
Healthcare professionals who use these catheters for medical procedures are affected. Patients receiving these catheters through a doctor's prescription are at risk.
Check for the part number 1013158-12 on the catheter packaging. The device is not cleared for US distribution and was sold with a specific lot number (90813G1).
Look for the part number 1013158-12 on the catheter packaging or label.
The recall states this device is not cleared for commercial distribution in the United States, so it should not be used.
The recall does not specify a remedy, so contact Abbott Vascular directly for guidance.
No, the device is not cleared for US distribution.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1144-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1144-2020 from Abbott Vascular. 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.