To Get Help Now
Medical Device Lawsuits
Click Here
 
Today's Date:

Cook Medical Cardiac Catheters Recalled Due to Faulty Tips

Nearly 39,000 Cook Medical Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters have been recalled because their tips may split or separate from the catheter, causing injury or even death.

The Food and Drug Administration (FDA) has classified this a Class 1 recall—the most serious recall category—for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. More Cook Medical Cardiac Catheters Recalled Due to Faulty Tips

Medtronic Core Valve-Related Recall is Deemed A Class I

Medtronic’s recall of its EnVeo R loading system for the CoreValve Evolut transcather aortic valve device has been designated as Class 1 by the U.S. Food and Drug Administration (FDA). The recall was issued last month due to reports of “particulate being observed in a small number of cases,” Medtronic’s CoreValve was first approved in early 2014 for patients at extreme or high risk of open-heart surgery. The device has also since been approved for “valve-in-valve” (VIV) replacement, where a valve is placed within a failing artificial heart valve.

Medtronic received eight complaints associated with this issue, according to a recall letter posted on the website of Germany’s Federal Institute for Drugs and Medical Devices. The particulate was observed during the valve loading procedure in six cases, and observed in the packaged kits in the other two cases. Medtronic notified customers of the recall in an urgent field safety notice, which stated that a blood clot could arise if particulate matter is mistakenly deployed while the Evolut device is being implanted. More Medtronic Core Valve-Related Recall is Deemed A Class I

Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection


A lawsuit has been filed against Arizant, a 3M subsidiary, alleging that its Bair Hugger forced-air surgical warming blanket caused a deep joint infection. The plaintiff in the case had been undergoing a hip implant revision surgery. Allegedly, the Bair Hugger introduced pathogens from the operating room floor into the surgical site and resulted in Methicillin-resistant Staphylococcus aureus (MRSA) infection. The septic arthritis, or deep joint infection, allegedly caused by the Bair Hugger forced the plaintiff to undergo another six surgeries in less than eleven months. He alleges that he is unable to move freely and continues to suffer physical damages.

The suit alleges although the Bair Hugger is used in 90 percent of major surgeries, it is especially risky in joint replacement and revision procedures. The surgical warming blanket may play a role in the thousands of orthopedic implant infections each year, the suit alleges. Arizant and 3M are accused of hiding the risks of the Bair Hugger. More Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits

Medtronic is Paying Millions to the InFuse Research Authors

Medtronic is Paying Millions to the InFuse Research Authors


Medtronic continues to pay millions of dollars to doctors who authored questionable research articles concerning the safety and effectiveness of the company’s InFuse spine growth product.

In 2014, Medtronic Sofamor Danek – Medtronic’s spine division – paid $60.7 million in royalties to 79 doctors and their affiliates, including to the authors of controversial studies of InFuse. Dr. Ken Burkus, a Georgia surgeon and the lead author on six InFuse studies that omitted adverse events, received $374,000 from Medtronic. Dr. Regis Haid, an Atlanta, Georgia, neurosurgeon and the lead author of one study, was paid $2.3 million in royalties. Both doctors received their payments from third-party companies. StarTribune.com reports the company paid $90 million in royalties last year. More Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits

Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Maquet's FLOW-i Anesthesia System Recalled

Maquet’s FLOW-i Anesthesia System Recalled


Some of Maquet’s FLOW-i Anesthesia Systems reportedly have a malfunction that could result in potentially fatal ventilation stops, the U.S. Food and Drug Administration (FDA) warned. A July 1st safety alert indicated that the issue “may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”

The systems are used in hospitals to provide anesthesia and ventilation support in patients who have difficulty breathing. The recall, which affects 1,641 units worldwide including 80 in the United States, was initiated in April. The FDA labeled its as Class 1 in June, which means that there is a reasonable possibility of serious injury or death associated with the issue. More Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Medtronic Unit Says It Will Settle Some of the 11,000 Transvaginal Mesh Lawsuits Facing the Company

Medtronic Will Settle 11,000 Transvaginal Mesh Lawsuits

Medtronic Will Settle 11,000 Transvaginal Mesh Lawsuits


Medtronic’s Covidien unit says it will settle some of the more than 11,000 transvaginal mesh lawsuits that have been filed on behalf of patients who allege the device caused them severe pain and serious side effects.

Covidien made the announcement Tuesday in a court filing in West Virginia federal court that was viewed by Reuters. Covidien said it could not disclose the amount of the settlement nor how many cases the confidential agreement with one of the plaintiffs’ law firms would resolve. More Medtronic Unit Says It Will Settle Some of the 11,000 Transvaginal Mesh Lawsuits Facing the Company

After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps

Medtronic Must Stop Selling Synchromed Drug Pumps

Medtronic Must Stop Selling Synchromed Drug Pumps


Medtronic must stop selling the majority of its implantable drug pumps due to years of unfixed problems, the U.S. Food and Drug Administration (FDA) said. Star Tribune reports that the agency has filed a court order stating that Medtronic must stop distributing and producing its Synchromed II drug pumps. The devices are surgically implanted to delivery a drug solution in the area surrounding the spine in patients with cancer, chronic pain and severe muscle spasms. The pumps were recalled because they may lose battery power and fail, causing harm to patients. The devices were also problematic in cases where they delivered the wrong amount of medication. Even though Medtronic has been aware of problems since 2006, they have failed to act; this lack of compliance has prompted to the FDA more aggressively assert its authority. More After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps

Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Tainted duodenoscopes, which have come under scrutiny in light of a series of superbug outbreaks, are also associated with an outbreak of drug-resistant Escherichia coli (E. coli) in a Washington state hospital. According to a study published in Infection Control & Hospital Epidemiology, patients can still be infected even when following manufacturers’ cleaning instructions.

An investigation revealed that between November 2012 and August 2013,32 patients were infected with an antibiotic-resistant strain of E. coli at Seattle Virginia Mason Medical Center. The hospital had followed the manufacturer’s cleaning protocol, but these procedures were apparently insufficient.

Recent evidence suggests that manufacturers’ cleaning instructions alone are not enough to sterilize duodenoscopes, a specialized type of endoscope. Recently, the devices were implicated in recent outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE) at two Los Angeles Hospitals: UCLA’s Ronald Reagan Medical Center and Cedars-Sinai hospital. A total of 11 patients were infected with CRE at the two hospitals and 246 more were potentially exposed.
More Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Settlement Deadline Extended for Patients Injured by Defective Stryker Hip Systems

Settlement Deadline Extended for Patients Injured by Stryker

Settlement Deadline Extended for Patients Injured by Stryker


The deadline to enroll in the Stryker Orthopedics Rejuvenate Hip System settlement has been extended to March 30, 2015.

Patients who were implanted with one of the now-recalled ABG II Modular Hip Systems or Rejuvenate Modular Hip Systems still have time to register with the settlement, which was announced in late 2014. More Settlement Deadline Extended for Patients Injured by Defective Stryker Hip Systems

FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer

FDA Hopes new Rules will Make Endoscopes Cleaner and Safer

FDA Hopes new Rules will Make Endoscopes Cleaner and Safer


Under new federal rules, endoscope manufacturers will need to prove to the U.S. Food and Drug Administration (FDA) that its devices can be thoroughly cleaned. The move comes on the heels of an outbreak of a superbug at two Los Angeles hospitals.

Duodenoscope manufacturers will now need to provide scientific evidence that duodenoscopes can be cleaned reliably, but the FDA cannot require manufacturers to change the design of the devices to make them easier to disinfect. The FDA said it was issuing new rules for cleaning the duodenscopes, along with a wide range of other reusable medical devices. The agency proposed the rules in draft form in 2011, but they were never finalized, the Los Angeles (LA Times) reported. More FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer