U.S. Food and Drug Administration02.19.20
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.
The NC TREK RX Coronary Dilatation Catheter is indicated for use in the following cardiac procedures:
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Abbott Vascular is recalling the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters, balloon diameters 4.0mm, 4.5mm, and 5.0mm because the balloons from the impacted lots may not deflate as intended. This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing.
Use of these devices may cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blow flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to post-operative complications, including death.
Abbott Vascular has received 13 complaints related to this issue. One death has been reported.
Patients who undergo cardiac procedures involving the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters and healthcare providers and hospitals using the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters may be affected
On January 29, 2020, Abbott Vascular issued an Urgent Recall Notification instructing customers to:
Recalled Product:
- NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters
- Models: Balloon diameters 4.0mm, 4.5mm, and 5.0mm
- Lots: See a full list of affected devices
- Distribution Dates: August 2019 to January 2020
- Devices Recalled in the U.S.: 13,891
- Date Initiated by Firm: January 29, 2020
Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart.
The NC TREK RX Coronary Dilatation Catheter is indicated for use in the following cardiac procedures:
- 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).
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Abbott Vascular is recalling the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters, balloon diameters 4.0mm, 4.5mm, and 5.0mm because the balloons from the impacted lots may not deflate as intended. This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing.
Use of these devices may cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blow flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to post-operative complications, including death.
Abbott Vascular has received 13 complaints related to this issue. One death has been reported.
Patients who undergo cardiac procedures involving the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters and healthcare providers and hospitals using the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheters may be affected
On January 29, 2020, Abbott Vascular issued an Urgent Recall Notification instructing customers to:
- 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.