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 …
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 …
Recalled Product MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots before October 2019 Model 670G (MMT-1780) – all lots before August 2019 Distribution Dates: Model 630G – September 2016 to October 2019 Model 670G – June 2017 to August 2019 Devices Recalled in the U.S.: 322,005 Date Initiated by Firm: November 21, 2019 Device Use People who …
This is a recall alert to all patients who received a Zimmer Persona implant prior to August 7, 2017. According to the recall filed with the FDA: “There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product(s): CoaguChek XS PT Test Strips purchased from Terrific Care, LLC. or Medex Supply Lot Numbers: All lot numbers sold by Terrific Care LLC. or Medex Supply Manufacturing Dates: October 2017 to May …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Name: DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member Serial numbers: 1704001, 1704042, 1709001, 1709096 Manufacturing Dates: May 4, 2017 to April 5, 2018 Distribution Dates: March 21, 2018 to …
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Studies have shown that, in some patients, bariatric surgery may lead to a severe vitamin deficiency that can cause memory loss and other serious neurologic problems. Cases of Wernicke’s encephalopathy — a syndrome caused by thiamine deficiency and marked by acute mental confusion, apathy, drowsiness, ataxia, and oculomotor abnormalities — have been reported in the medical literature in patients who …
FDA issues new warning against homeopathic teething tablets The U.S. Food and Drug Administration (FDA) is warning against the use of homeopathic teething tablets after lab analysis found inconsistent amounts of belladonna, a toxic substance that could post a risk to infants and children who consume it. Standard Homeopathic Company, the manufacturer behind Hyland’s homeopathic teething products, has not agreed …
In the case of Wood v. Verticor, The Meyerson Law Firm recently won a long hard fight where the manufacturer of a medical device claimed that the fraud and negligence causes of action where claims against a health care provider. They alleged that as such, the Plaintiff Mr. Wood would have to file a detailed expert report and be subjected …
