Current Events

Abbott (NYSE:ABT) has issued an urgent field safety notice looking to recall select coronary dilation and balloon catheters over issues with inflating and deflating the balloons.

The company said it is recalling specific lots of the NC Trek RX coronary dilation catheter, the NC Traveler RX coronary dilation catheter and the NC Tenku RX PTCA balloon catheter over issues with removing the protective balloon sheath which can result in issues inflating or deflating the balloon.

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MDLive has been hit with a class-action lawsuit accusing the telehealth provider of violating patients' privacy rights. 

The lawsuit, filed Tuesday in a Florida federal court, alleged MDLive shared detailed patient health information with a third-party tech company without the patients' consent. The tech company, Israel-based Test Fairy, uses health information to fix bugs with MDLive's mobile app and to test users' experience. 

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A woman who developed an incredibly rare but potentially deadly cancer linked to certain breast implants is warning other women to stay vigilant about their bodies.

Stacey Boone was told she had the flu, endured an egg-size lump on her collarbone and lost more than 40 pounds before she finally received the correct diagnosis: breast implant-associated anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin's lymphoma.

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Despite laws restricting talking and texting while driving in many states, a shocking new survey out Monday found nearly 90 percent of drivers said they used their smartphones while on the road.

On average, drivers spent 3.5 minutes per hour on their phones, the Zendrive study discovered, a frightening finding because a 2-second distraction increases the likelihood of a crash by 20 times.

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A high rate of heart attacks in European patients following implantation of its Absorb GT1 bioabsorbable drug-eluting stent has prompted Abbott Laboratories to begin monitoring surgeons’ implantation techniques.

Absorb has also been implicated in reported deaths of nearly 20 U.S. patients in 2016 and 2017, according to FDA’s adverse event database. Several of those reports, which were submitted by either Abbott or a healthcare provider, mentioned stent-related blood clots (stent thromboses) as a possible contributing factor.
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The U.S. Food and Drug Administration (FDA) has raised concerns over manufacturing controls at a Teva Pharmaceutical Industries plant in China, Israel's biggest company said in a regulatory filing on Thursday.

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The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of cardiovascular devices acquired with its purchase of St. Jude Medical in January for $25 billion.

The letter, dated April 12 and made public on Thursday, sent Abbott's shares down 2 percent to $42.
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The US health regulator has issued a warning letter to drug firm Mylan for violations of good manufacturing norms, including data integrity lapses and failure of quality control at its Nashik facility.

The letter by the United States Food and Drug Administration (USFDA) to the Mylan Pharmaceuticals Inc President Rajiv Malik states that it had inspected the Nashik facility of the company from September 5 to 14, 2016.

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Cook Medical this week released information on a select voluntary recall of its Bush DL and Bush SL ureteral illuminating catheter sets over issues with overheating.

The Bloomington, Ind.-based company said it has received an increased number of reports of the proximal black component that connects to the distal transparent component overheating and melting, which could potentially cause burns.

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Inspectors with the U.S. Food and Drug Administration on Wednesday slapped St. Jude Medical with a warning letter accusing the medical device maker of failing to properly investigate problems with the batteries in its implantable defibrillators and the cybersecurity of its at-home monitoring equipment.

The inspectors said that company officials systematically underestimated the true risks facing heart-device patients, even after one person died in 2014.
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Over the past several years, there have been multiple recalls involving implant devices because of the dangerous risks they pose to patients. These recalls have included devices use for hip replacement and for knee replacements. Recently, the Food and Drug Administration announced a new recall — this time for shoulder implant devices.

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