NC Trek RX (coronary catheters)

2020: A withdrawal of the rejected coronary catheters

At the end of January, 2020 Abbott began to withdraw a number of coronary dilatatsionny catheters with the market. The response belongs to the I class - the most serious type of a response which concerns devices, life-threatening the patient.

The response initiated by Abbott on January 29, 2020 covers about 14,000 catheters for dilatation of coronary arteries of NC Trek RX and balloon catheters for dilatation of coronary arteries of NC Traveler RX with cylinders with a diameter of 4.0 mm, 4.5 mm and 5.0 mm. Abbott extended these catheters in the market from August, 2019 to January, 2020.

Abbott began to withdraw a number of coronary dilatatsionny catheters with the market

According to data of regulatory bodies, cylinders of affected catheters are not always blown off as it was supposed. The problem resulted from excessive influence of heat during production - material near balloon connection weakened and cannot support the set parameters.

Potential risks when using defective products include an air embolism, thrombosis, a myocardial infarction and additional surgery. Abbott received 13 complaints connected with this problem and also the report on one lethal outcome.

According to the website of regulatory bodies, personnel and affiliates of the company directly contacted the first clients who are out of control of firm by phone, e-mail or at personal visit as soon as possible to convey this information. The company issued the express notice about a withdrawal of the rejected coronary catheters and urged to stop immediately to clients their use. All catheters included in a response can be returned to the company for exchange and the subsequent utilization of the rejected devices.

Also it is said in the statement that the company "Abbott stopped shipment of the rejected batches and took remedial measures to ensure safety of products".^[1]

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