Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to be introduced into patients who have procedures with this device. Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat (tachycardia or bradycardia), low blood pressure (hypotension), and lack of enough oxygen in the blood (desaturation). Air embolism can also potentially lead to serious health consequences including stroke and death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to be introduced into patients who have procedures with this device. Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat (tachycardia or bradycardia), low blood pressure (hypotension), and lack of enough oxygen in the blood (desaturation). Air embolism can also potentially lead to serious health consequences including stroke and death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition- FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use infant head shaping pillows intended to change an infant’s head shape and/or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows. These infant head shaping pillows are unapproved medical devices that may create an unsafe sleep environment. The safety communication provides important information about unapproved infant head shaping pillows, including: Background on the potential risk of death or injury in infants. ...

The U.S. Food and Drug Administration (FDA) continues to warn consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands. Do not use these UV wands because they may expose you or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use. If you or a loved one has purchased a wand, call our firm today at 512-330-9001.

Integra is recalling the CereLink ICP Monitor, Model #826820/826820P, after reports that the device may display incorrect values for a patient’s intracranial pressure and display out-of-range pressure readings. If the device is not working properly, the patient may have to undergo additional brain surgeries to replace it, which involves the risks of infection, bleeding, and damage to tissue. Additionally, because the device is used to inform decision-making in critically ill patients (including people with severe traumatic brain injury and stroke) and managing intracranial pressure is key to their care, a malfunctioning device creates a risk of serious injury or death. Integra reported that there have been 105 global complaints associated with this recall as of ...

Medtronic, Inc. is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs, batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. If you’ve experienced this issue, call our firm today to discuss.

On December 29, 2021, Baxter Healthcare issued an Urgent Safety Communication regarding the SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion can cause the pump to not re-alarm as expected. The pump adjusts occlusion detection after the user acknowledges an upstream occlusion alarm; for the remainder of that infusion, the upstream occlusion alarm will not alarm per its baseline settings. If an occlusion is not fully resolved before restarting the infusion, the pump ...

A toddler in Lincoln, Nebraska was seriously injured from a button battery that came from a mini Christmas tree decoration that his mother purchased at Target.  The Meyerson Law Firm investigation has determined the lighting tester button contains a button battery that can be easily accessed by tugging on the wire.  This makes the device non-compliant with UL safety standard 4200A and dangerous to children.  And, it appears that this same testing button design is on multiple similar Target Christmas products.  Button batteries are extremely dangerous to toddlers.  They can lodge in the esophagus and quickly create caustic burns.        

The Meyerson Law Firm is representing the mother of a child in New York City who was injured swallowing a button battery that came from a Midea Air Conditioner remote control.  The housing for the battery in the remote at issue opens without the need of a coin or tool. The Consumer Products Safety Commission has been notified.

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