Abbott recalls NC Traveler Coronary Dilatation Catheters (REF 1013157-15) due to potential balloon deflation issues. This device is not cleared for U.S. distribution and may cause complications during procedures.
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 during medical procedures. This could lead to complications if the catheter is used improperly.
The catheter's balloon may not deflate properly during use, which could cause blockages or complications in the blood vessels. This issue occurs because the device is not cleared for U.S. distribution and may not function as intended.
Healthcare professionals using the device for coronary procedures are affected. Patients receiving these catheters during medical treatments may be at risk.
Check for the part number 1013157-15 on the catheter packaging. The device was sold with lot numbers starting with 91102G1 and is not cleared for U.S. distribution.
Look for the part number 1013157-15 and lot numbers starting with 91102G1 on the catheter packaging.
The device is not cleared for commercial distribution in the United States and may not function as intended, so it should not be used.
The official recall notice does not specify a remedy, so contact Abbott Vascular directly for guidance.
The catheter may have difficulty or inability to deflate the balloon during medical procedures, which could lead to complications.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1142-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1142-2020 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.
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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.
