The HawkOne system has a motorized cutter and a catheter that are intended to remove plaque buildups from peripheral arteries. The device's guide wire, which can bend and stick outward, is the cause of the problem. There are reports of ruptured and blocked blood vessels requiring surgical repair
Following complaints of accidents associated with their HawkOne system for unclogging blocked arteries, Medtronic has recorded yet another Class I medical device recall, the FDA's most serious classification. The FDA received 163 complaints and determined an urgent recall was needed.
Followed by Ventilators Recall
According to the FDA notification, a total of 278 ventilators that have been supplied globally are included in the recall. The issue is related to a mistake in the ventilators' capacitor assembly during the manufacturing process, which might lead to the devices malfunctioning in the middle of operation.
The FDA didn't specify how many complaints about the manufacturing fault were submitted to the organization or whether any injuries or fatalities were associated with the problem.
Medtronic did not require that the device be delivered back to the manufacturer in its December communication to healthcare providers, which is included in the FDA recall notice. The current cautions and warnings in the HawkOne instructions regarding the possibility of prolapsed guide wires were also reaffirmed in the letter.
Patients who received operations without incident are exempt from further action, according to the business, and existing patients should be followed up on as usual.