Three Companies’ Cardiac Devices Deemed Class I Recalls

This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious injury or death.

On June 12, Abbott sent a recall letter to customers advising that their cardiac catheter, Amplatzer Steerable Delivery Sheath, presented an increased risk for the introduction of air bubbles (air emboli) into the body. An air embolism can potentially lead to serious health outcomes such as stroke or death.

Abiomed began the recall for its Impella Left Sided Blood Pump on June 14, explaining in a letter to customers that the pumps’ instructions for use “do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR),” the FDA said.

Contact between an Impella and the distal stent of a TAVR may damage or destroy the motor’s impeller blades, the FDA said, leading to reduced blood flow or pump stop, which could be life threatening. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.

GE HealthCare TruSignal SpO2 sensors, recalled started March 19, continuously monitor pulse rate as well as the amount of oxygen flowing through the arteries through a skin sensor, used for both adults and children.

The company is recalling certain of the sensors for several issues: the sensor may reduce the amount of energy sent to the heart during defibrillation, unintentionally expose patients to electrical currents from other sources, or may provide inaccurate blood oxygen level measurements. The company has provided recommended actions for use of the device.

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