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Nc Trek

4600.00

Brand Abbott
Company Abbott
SKU BISITERUMONC
Location Jaipur
product details

Who May be Affected

  • Patients who undergo cardiac procedures involving the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters.
  • Health care providers and hospitals using the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters.

What to Do

  • Immediately stop using affected devices from the lots affected by this recall.
  • Review your inventory, complete, and return the attached Effectiveness Check Form.
  • Return all unused affected product to Abbott Vascular.
  • Share the notification with other relevant personnel in your organization.

Device Use:

Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.

  • balloon dilatation of the abnormal narrowing portion of a coronary artery or bypass graft, for the purpose of improving myocardial perfusion
    • balloon dilatation of a coronary artery occlusion, to restore coronary flow in patients who have had a type of heart attack, known as myocardial infarction – specifically patients with ST-segment elevation, which refers to the flat section of an electrocardiogram (ECG) reading and represents the interval between heartbeats.
    • balloon dilatation of a stent after implantation (balloon models 4.00 mm – 5.00 mm only).
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