FDA Labels Medtronic’s HawkOne Recall Class I or ‘Most Serious’

Product recall

The U.S. Food and Drug Administration (FDA) has labeled Medtronic’s recall of the HawkOne Directional Atherectomy System a Class I event adding to the company’s long list of product safety problems.

According to an alert issued by the FDA, Medtronic issued the recall of the medical device on Dec. 6 because of the risk that guide wires in the catheters can alter their positions when force is applied during use.

According to the FDA, the HawkOne Directional Atherectomy System consists of a catheter and a cutter driver. This device is used during procedures intended to remove blockages from peripheral arteries and improve blood flow.

Injuries Reported from HawkOne Use

The malfunction could result in the catheter tip breaking off or separating, which could then cause a tearing of the inside wall of an artery, a rupture or break of an artery, reduced blood flow to parts of the body due to a blocked artery and/or blood vessel complications that might require surgical repair.

Product malfunctions can also require additional procedures to capture or remove the detached tips or tips that have migrated to other parts of the body. So far, 163 complaints have been received with regard to these defective medical devices including 55 injuries. So far, no deaths have been reported. The recall affects 95,110 devices in the United States. The FDA has classified this as a Class I recall, which means it is “most serious” involving products that could cause serious injury or death.

Medtronic is continuing to face more product safety issues. In 2021 alone, the FDA posted 10 Class I recall notices for the company including MiniMed insulin pumps and several recalls for the HeartWare ventricular assist device, which was eventually pulled from the market in June. This year, FDA has posted three Class I recall notices for Medtronic.

Medical Devices and Product Liability

When it comes to medical devices that are implanted in patients’ bodies, the only way to correct problems is to perform surgery or other invasive procedures to remove or repair the device. If these interventions are not done in time, the patient could suffer serious injuries or even death.

In such cases, a number of different persons or entities may be held liable for injuries and damages suffered by victims. A manufacturer, supplier, or seller of the defective device could also be held liable. A physician, healthcare provider, or hospital that implanted a faulty device can be held accountable as well.

If you or a loved one has been injured by a defective medical device, you may be able to seek compensation for damages such as medical expenses, lost income, cost of surgery, hospitalization, and rehabilitation, as well as pain and suffering. An experienced product defect attorney can help you better understand your legal rights and options

 

Source: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-hawkone-directional-atherectomy-system-due-risk-tip-damage-during-use

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