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FDA Cites HeatWare for Controller Failures Linked to Two Deaths

The U.S. Food and Drug Administration (FDA) has published a letter that accuses HeartWare International of design and software malfunctions that may have led to serious injuries and death.

In the letter, the FDA said it was notified that HeartWare received 27 complaints about controller failure for its ventricular assist device, of which electrostatic discharge was determined to be the most likely cause, the Worcester Business Journal reported. Included in the complaints are reports of two deaths and four serious injuries. More FDA Cites HeatWare for Controller Failures Linked to Two Deaths

Vascular Solutions’ Catheter recall gets Class I status

The U.S. Food and Drug Administration (FDA) has given Class I status to Vascular Solutions’ recall of certain lots of its Langston V2 Dual Lumen Pressure Monitoring Catheter.

The recall was initiated on May 27. Affected devices were manufactured from January to April, and distributed from March to May, according to the FDA release. More Vascular Solutions’ Catheter recall gets Class I status

Class I Status Given to Medtronic Duet System Recall

The U.S. Food and Drug Administration (FDA) placed a Class I label on Medtronic’s recall of its Duet system, used to drain cerebrospinal fluid and monitor intracranial pressure.

“Medtronic’s Duet External Drainage and Monitoring System (EDMS) externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP),” the FDA notice said. “The device is intended to be used only when trained personnel are present to supervise monitoring and drainage 24-hours a day.” More Class I Status Given to Medtronic Duet System Recall

DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

DePuy Orthopaedics Inc. has been ordered to pay $4 million to settle allegations by the Oregon Department of Justice (ODOJ) that the medical device maker knowingly marketed faulty ASR XL metal-on-metal (MoM) hips.

The ASR XL all-metal hip device was intended to last 15 years, but studies showed the devices failed much sooner than expected. Data collected from the National Joint Registry of England in 2010 revealed that one in every eight patients (12 percent to 13 percent) had to undergo revision surgery within five years of receiving it.The hips have caused thousands of patients to experience pain, swelling, bone and muscle damage, and difficulty walking. More DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Managed care company Humana has sued Medtronic Inc., accusing the company of falsely representing its Infuse bone growth device as safe and effective in spinal fusion surgeries.

Humana filed the lawsuit in federal court in Tennessee on Friday. The complaint alleges that Medtronic paid for academic literature that fraudulently portrayed Infuse as safe and effective for off-label uses. According to court documents, Humana said that Medtronic engaged in a “sophisticated and deeply deceptive marketing strategy” designed to expand the market for Infuse, by urging and compensating spine surgeons to use the device by over-emphasizing its benefits and downplaying its serious risks, Reuters reported. More Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Medtronic Tries to Settle Infuse Cases but Many Patients May Still See Their Day in Court

More than 6,500 reports of injuries related to Medtronic’s Infuse bone growth product have flooded into the U.S. Food and Drug Administration (FDA) since 2002. About 3,300 were registered with the agency’s medical device reporting system last year alone. Now, the company is settling as many cases as possible while patients await their day in court.

Medtronic told investors last week that it will pay $22 million to settle about 950 claims and is setting aside $140 million to settle future claims, according to MedPageToday.com. More Medtronic Tries to Settle Infuse Cases but Many Patients May Still See Their Day in Court

HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp.

This week, the U.S. Department of Health and Human Services (HHS) subpoenaed Boston Scientific Corporation for information relating to the medical device maker’s 2008 launch of two brands of implantable cardiac defibrillators (ICDs) and their performance between 2007 and 2009, as well as the operation of a “Physical Guided Learning Program.”

The defibrillators are sold under the brand names Cognis and Teligen, according to the Wall Street Journal (WSJ). More HHS Probes Cardiac Defibrillators Manufactured by Boston Scientific Corp.

Morcellators Used in Fibroid Surgeries Could Spread Unseen Cancer, Johnson & Johnson Warns

Johnson & Johnson (J&J) has suspended the sale of morcellators, which are devices used in fibroid surgeries, over concerns that they can spread a type of rare but deadly cancer.

The medical device maker is stopping the world-wide sale, distribution, and promotion of laparoscopic power morcellators, but is not permanently pulling them from the market, according to Reuters. More Morcellators Used in Fibroid Surgeries Could Spread Unseen Cancer, Johnson & Johnson Warns

Uterine Fibroid Procedure May Cause Cancer, FDA Warns

The U.S. Food and Drug Administration (FDA) advised doctors on Thursday to stop using power morcellators in laparoscopic uterine fibroid removal surgeries because of cancer concerns. The agency said the surgical technique could unexpectedly spread cancerous tissue into a patient’s stomach.

The FDA recommended that doctors look into other treatment methods for symptomatic fibroids rather than using the tool to remove fibroids or a woman’s uterus laparoscopically, according to Law360. Despite the severity of the risks, the agency didn’t remove the nearly two-dozen power morcellators from the market. More Uterine Fibroid Procedure May Cause Cancer, FDA Warns

Intuitive Sales Drop as Da Vinci Lawsuits Pile Up

In a year where Intuitive Surgical has issued a series of recalls and been hit with an influx of lawsuits, the company is also seeing financial woes.

Intuitive announced its first-quarter revenue declined about 24 percent as sales of its robotic surgery system took a plunge. In a statement released by Intuitive, the company said it shipped 87 robots in the first quarter compared with 164 a year earlier. Intuitive also suffered a charge of $67 million to reflect estimated costs of settling product liability claims. Most of the claims are related to alleged complications from surgeries performed with certain robotic scissors or tip covers that have since been taken off the market, Bloomberg News reported. More Intuitive Sales Drop as Da Vinci Lawsuits Pile Up