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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

In New York City, an Average of One Passerby per Month is Injured in a Construction Accident

A new Department of Buildings analysis shows that in New York City, an average of one passerby per month is injured in a construction accident.

An average of one passerby per month is injured.


A new Department of Buildings analysis shows that in New York City, an average of one passerby per month is injured in a construction accident.

A Wall Street Journal investigation which focused on passerby injuries, rather than injuries to both construction workers and passersby, found that 96 construction accidents involving passersby occurred between 2008 and 2014, resulting in 155 injuries. More than three-quarters of the accidents happened in Manhattan, according to The Real Deal. More In New York City, an Average of One Passerby per Month is Injured in a Construction Accident

U-Haul Slams into Teenage Boy in the Bronx, Critically Injuring him

U-Haul Slams into Teenage Boy in the Bronx

U-Haul Slams into Teenage Boy in the Bronx


A U-Haul truck hit a 17-year-old boy on Friday morning in the Bronx in New York City on Friday morning, seriously injuring him.

Amary Milan was on his way to Samuel Gompers High School on Friday morning when he was struck by a U-Haul driven by Efram Rodriguez, 36, at around 8:38 a.m. in the Longwood section of the Bronx. Witnesses told CBS New York that Milan was walking in the crosswalk trying to cross Southern Boulevard when the U-Haul truck ran a yellow light and struck him. Milan was thrown more than 10 feet and seriously injured. More U-Haul Slams into Teenage Boy in the Bronx, Critically Injuring him

OxyElite Pro Found to Contain Prozac

OxyElite Pro Found to Contain Prozac

OxyElite Pro Found to Contain Prozac


The U.S. Food and Drug Administration (FDA) told consumers on February 28 to be extra vigilant when purchasing weight loss supplements, specifically mentioning OxyElite Pro, which was found to contain a powerful antidepressant drug.

OxyElite Pro is a thermogenic supplement. It is designed to boost metabolism and burn fat, but it increases the body’s internal temperature. More OxyElite Pro Found to Contain Prozac

Jury Rules Toyota Motor Co. was 60 Percent Responsible for Fatal Camry Crash

Jury Rules Toyota was 60% Responsible for Fatal Crash

Jury Rules Toyota was 60% Responsible for Fatal Crash


A federal jury on Tuesday decided that Toyota Motor Co. was partly to blame for a 2006 car crash that killed three people and left two seriously injured, and resulted in a wrongful conviction.

The jury awarded the victims and their family members $11 million after concluding that Toyota was 60 percent to blame for the accident. The case revolved around Koua Fong Lee, who in 2006 was driving his 1996 Toyota Camry when it accelerated wildly into traffic and crashed into another vehicle, killing the driver of the other vehicle, Javis Trice-Adams Sr., and his 9-year-old son, Javis Adams Jr. His 6-year-old niece, Devyn Bolton, was paralyzed and died in October 2007. His daughter, Jasmine Adams, then 12, was seriously injured, as was his father, Quincy Ray Adams. Those two and Devyn Bolton’s mother, Bridgette Trice, were the other plaintiffs in the case, along with Lee and four of his family members who were in his car at the time of the crash, according to the Associated Press (AP). More Jury Rules Toyota Motor Co. was 60 Percent Responsible for Fatal Camry Crash

New York City Council Joins the Fight to Reauthorize the Zadroga Act

NYC Council Joins the Fight to Reauthorize the Zadroga Act

NYC Council Joins the Fight to Reauthorize the Zadroga Act


New York City Council members have joined in the fight to ensure that the firefighters and rescuers of September 11, 2001 are never forgotten by pushing for the reauthorization of the Zadroga Act.

The council members are joining the effort to introduce a resolution that calls for Congress to reauthorize the Zadroga Act. The primary sponsor and co-sponsor for the effort are Councilwoman Margaret Chin (Democrat – Manhattan) and Melissa Mark-Viverito (Democrat – Manhattan/Bronx) respectively, along with two other members. More New York City Council Joins the Fight to Reauthorize the Zadroga Act

Researchers say the Liquid Found in E-Cigarettes is Dangerous Even if it Doesn’t Contain Nicotine

Researchers say Liquid Found in E-Cigarettes is Dangerous.

Researchers say Liquid in E-Cigarettes Dangerous


According to a new study from National Jewish Health in Denver, the liquid found in e-cigarettes significantly increases the risk for viral infections in users, whether it contains nicotine or not.

By taking cells from the airways of young, healthy non-smokers and exposing them to the liquid or vapors from e-cigarettes, researchers were able to determine that inhaling the vapor can damage epithelial cells and increase the risk of infections. The scientists discovered that when they exposed the cells to the liquid or vapors in the lab, it only took 10 minutes for a reaction to occur, according to the National Jewish Health (NJH) website. More Researchers say the Liquid Found in E-Cigarettes is Dangerous Even if it Doesn’t Contain Nicotine

Three Injured, Two Seriously, After Train Strikes a Livery Cab in New York

3 Injured, 2 Seriously, After Train Strikes Livery Cab in NY

3 Injured, 2 Seriously, After Train Strikes Livery Cab in NY


A livery cab was struck by a Long Island Rail Road (LIRR) train after it somehow got onto the tracks west of Wyandanch station last Wednesday.

A Lincoln Town Car was hit by a LIRR train at the crossing on Straight Path about 1:20 p.m. on January 7. How the vehicle got on the tracks remains a mystery. The train, carrying 500 passengers, was heading east from Penn Station, due at Ronkonkoma at 1:37 p.m. The driver of the cab was taken to Good Samaritan Hospital Medical Center, LIRR spokesman Salvatore Arena told New York Newsday (Newsday). A female passenger was airlifted to Stony Brook University Hospital. The engineer suffered a shoulder injury and was taken to Southside Hospital in Bay Shore.  PIX 11 reported that both the driver and the passenger were critically injured. More Three Injured, Two Seriously, After Train Strikes a Livery Cab in New York

Widow of School Bus Driver who Died from Mesothelioma Awarded $7.7 Million

A New York state jury has decided that Navistar International Corp. must pay $7.7 million to the family of a man who died from a serious lung disease known as mesothelioma after being exposed to asbestos in one of the company’s garages.

The wrongful death suit was brought by the widow of a school bus driver who died of mesothelioma as a result of being exposed to asbestos in the school district’s garage. The complaint, viewed by Law360, alleges the man began working for the Fayetteville-Manlius School District in Manlius, New York, as a bus driver in the 1950s. He spent many hours in the garage over the years, clocking in for his routes, submitting work orders and speaking with mechanics. More Widow of School Bus Driver who Died from Mesothelioma Awarded $7.7 Million

Federal Regulators Promise to Investigate Deadly Takata Airbags

Federal safety regulators have pledged to delve deep into an investigation of deadly Takata airbags, which have prompted 10 automakers to recall more than 12 million vehicles globally.

U.S. Senators Richard Blumenthal (D-Conn.) and Ed Markey (D-Mass.) said on Friday the Justice Department needs to open a criminal investigation into allegations of a cover-up at least a decade old. The National Highway Traffic Safety Administration (NHTSA) believes Takata has had serious problems with its airbags dating back to 1998, years before the air bag and safety-belt supplier is alleged to have quietly tested dozens of airbags after one of the bags malfunctioned in an Alabama crash that sent shrapnel flying into the passenger compartment, injuring the driver, according to USA Today. More Federal Regulators Promise to Investigate Deadly Takata Airbags