- FDA flagged a series of high-risk recalls Wednesday from Abbott Vascular, ResMed and Teleflex, placing them in the agency’s top risk category due to the potential for serious injury or death if the devices malfunction.
- Abbott and ResMed each reported the death of a patient in connection with their recalls.
- Abbott is recalling certain NC Trek RX and NC Traveler RX Coronary Dilatation Catheters; ResMed is recalling certain Stellar ventilators; and Teleflex is recalling certain Comfort Flo Humidification Systems.
FDA identified each of the following device recalls as Class I:
Abbott coronary catheters
Abbott is recalling the coronary catheters because the balloons may fail to deflate as intended. That's because of potentially weaker material near the balloon bond caused by excessive exposure to heat during manufacturing.
Use of the devices could lead to serious health problems including reduced blood flow to the heart, air embolism, blood clots, heart attack or additional surgery with potential for post-operative complications, including death, FDA said.
Abbott received 13 complaints about the catheters, and one death was reported. The recall affects 13,891 devices in the United States. The devices were distributed from August 2019 to January 2020.
The recalled lots involve balloons with diameters of 4.0mm, 4.5mm and 5.0mm.
ResMed is recalling its Stellar non-invasive and invasive ventilators because the sound alarm may fail to work if the device has a failed electronic part, is stored without AC power connected for more than 36 hours (letting the battery drain completely), and the device powers on automatically when connected to AC power without the power switch being pressed.
One death was reported in connection with the recall. The ventilators provide breathing support to adult and pediatric patients who are non-ventilator dependent and spontaneously breathing, and are used in hospitals and homes and with wheelchairs.
Sixty-nine of the ventilators are being recalled in the United States. The devices were manufactured between April 2016 and June 2017 and distributed between April 2016 and November 2017.
Teleflex humidification systems
No deaths were reported in connection with the recall of Teleflex Comfort Flo Humidification Systems. The devices are being recalled because water could enter the circuit in the system and reach the patient’s nose and lungs, potentially causing serious health issues such as low oxygen in the blood or the need for treatment to prevent injury.
There were 102 complaints and eight injuries related to the device, including low blood oxygen and slower than normal heart rate.
The recall affects 398,320 devices in the United States, manufactured from October 2014 to June 2019 and distributed from October 2014 to October 2019.
Correction: A prior version of this story included an FDA misstatement on the conditions necessary for a sound alarm to fail. It's been corrected to indicate that a failed electronic part, a fully drained battery, and the device powering on automatically when connected to AC power without the power switch being pressed must all occur for the alarm to fail.