Abbott Vascular recalls NC TREK Coronary Dilatation Catheters (REF 1012454-20) 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 1012454-20) because they may have trouble deflating the balloon during medical procedures. This could lead to complications in treating heart conditions.
The catheter's balloon may not deflate properly during medical procedures. This could cause blockages or damage to coronary arteries, potentially leading to serious complications during heart treatments.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients undergoing heart-related treatments with this specific catheter model may be affected.
Check for the product name 'NC TREK Coronary Dilatation Catheter', reference number 1012454-20, and lot numbers 90801G1, 91018G1, 90809G1, or 91021G1. The catheter is only available by prescription.
Verify the reference number and lot numbers listed in the recall notice to confirm if your catheter is affected.
The recall indicates a potential issue with balloon deflation, so it is not recommended for use until the manufacturer addresses the problem.
Contact Abbott Vascular directly to confirm if your specific catheter model is affected and follow their instructions.
Check for the reference number 1012454-20 and lot numbers 90801G1, 91018G1, 90809G1, or 91021G1 on the catheter packaging.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1135-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1135-2020 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.
