Abbott recalls NC TREK Coronary Dilatation Catheters (REF 1012453-15) 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 is recalling NC TREK Coronary Dilatation Catheters that may have trouble deflating the balloon during medical procedures. This could lead to complications in treating heart conditions if the balloon doesn't deflate properly.
The catheter's balloon may not deflate properly during medical procedures, which could cause blockages or complications in coronary artery treatments. This risk is specific to the catheter's design and use in heart procedures.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients receiving these treatments may also be affected if the catheter is used incorrectly.
Check for the product name 'NC TREK Coronary Dilatation Catheter' with reference number 1012453-15. The catheter was sold with lot numbers including 90815G1 through 91117G1.
Review the product's reference number and lot numbers to confirm if it's affected.
The recall indicates a potential issue with balloon deflation, so it's recommended to check if your catheter is affected before use.
The recall does not specify a remedy, so contact Abbott Vascular directly for guidance.
Look for the reference number 1012453-15 and lot numbers from 90815G1 through 91117G1.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1130-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1130-2020 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.