Abbott Vascular recalls NC TREK Coronary Dilatation Catheters (REF 1012454-15) due to potential balloon deflation issues. This may affect medical procedures requiring coronary artery dilation.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters (REF 1012454-15) 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 medical procedures, which could cause blockages or complications in coronary arteries. This risk is specific to medical use and not typical consumer use.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used incorrectly.
Check for the product name 'NC TREK Coronary Dilatation Catheter' with reference number 1012454-15. The catheter was sold with lot numbers 90819G1, 90927G1, 90819G2, 90930G1, 90916G1, 91031G1, and 90916G2.
Verify the product reference number and lot numbers listed in the recall notice.
The recall states the catheter may have difficulty deflating the balloon, which could cause complications during medical procedures. It is not safe to use without checking the recall.
The recall does not specify a remedy, so contact Abbott Vascular directly for guidance.
Check for the reference number 1012454-15 and lot numbers 90819G1, 90927G1, 90819G2, 90930G1, 90916G1, 91031G1, or 90916G2.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1134-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1134-2020 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.
