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Ventricular Assist System Controllers Recalled due to Electric Shock Risk

Ventricular Assist System Controllers Recalled

Ventricular Assist System Controllers Recalled

HeartWare International Inc. has recalled its older HeartWare Ventricular Assist System Controllers in the United States because they are much more vulnerable to the risk of an electrostatic discharge (ESD) event, which could result in serious injury or death.

The company issued letters to clinicians and patients warning of the problem. The later commercial controllers are not affected by the recall, as the firm has made significant design improvements to them.  HeartWare first issued a Field Safety Corrective Action in April 2013. The medical device maker expects that the recall will affect about 120 patients in the U.S. Since the notice was issued, HeartWare has received one additional report of death and one injury due to ESD. The recalled Ventricular Assist System Controllers were distributed during the course of a clinical trial period, before the devices were approved by the U.S. Food and Drug Administration (FDA), according to ZACKS.com. More Ventricular Assist System Controllers Recalled due to Electric Shock Risk

Heart Monitor App Crashes, Prompting Recall

AliveCor has recalled one of its heart monitor apps due to the app crashing upon use.

More than 5,000 active iOS users are affected by the recall, the U.S. Food and Drug Administration (FDA) said in a recall notice. The AliveECG app works in tandem with the AliveCor Heart Monitor to record electrocardiograms and detect the presence of atrial fibrillation and normal sinus rhythm when prescribed by or under the guidance of a physician. The FDA has designated this as a Class III recall, according to HITConsultant.net More Heart Monitor App Crashes, Prompting Recall

Health Officials Learned of the Link Between Duodenoscopes and Superbugs in 2009

Defectively designed duodenoscopes may have exposed many as 179 patients to a “superbug” at UCLA’s Ronald Reagan Medical Center in Los Angeles, and U.S. health regulators have known about the problem since at least 2009.

Reuters reports that the U.S. Food and Drug Administration (FDA) has not recommended any new safety requirements, despite the fact that it knew as far back as 2009 that duodenoscopes can spread potentially deadly, multidrug-resistant superbugs. Last Thursday, the agency issued a “safety communication,” warning healthcare providers that the “complex design” of duodenoscopes could make them difficult to clean, but offered no further recommendations. For the first time, the FDA said that patients have still contracted deadly bacteria from the devices, even after hospitals strictly followed the manufacturer’s sterilization instructions. More Health Officials Learned of the Link Between Duodenoscopes and Superbugs in 2009

Nearly 800 Patients Possibly Exposed to Superbug at Large Los Angeles Hospital

800 Patients Exposed to Superbug at Los Angeles Hospital

800 Patients Exposed to Superbug at Los Angeles Hospital

Endoscopy procedures at the University of California, Los Angeles (UCLA) hospital may have exposed 179 patients to a multidrug-resistant superbug.

Seven endoscopy patients at the University of California, Los Angeles (UCLA), have been confirmed to have the carbapenem-resistant Enterobacteriaceae, or CRE, including two who died. The hospital warned 179 more patients that they may have been exposed to CRE and offered them home testing kits that would be analyzed by the hospital system, according to Reuters. More Nearly 800 Patients Possibly Exposed to Superbug at Large Los Angeles Hospital

MRI Systems Recalled Over Connection Issues

MRI Systems Recalled Over Connection Issues

MRI Systems Recalled Over Connection Issues

A Class I recall has been issued for almost 13,000 General Electric MRI systems due to a potentially life-threatening technical problem.

The recall affects more than 12,968 MRI systems and numerous brands, including Signa and Discovery. The recall includes 5,708 devices in the United States and 7,260 in other countries. The U.S. Food and Drug Administration (FDA) said in a February 18 Class I recall notice that “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries.” A Class I recall indicates that the affected device has the potential to cause serious injury or death. It is the FDA’s most serious recall designation. More MRI Systems Recalled Over Connection Issues

Design Defect in Duoendoscopes Makes Sterilization Difficult and May Spread Drug-Resistant Infections, FDA Warns

Design Defect in Duoendoscopes Makes Sterilization Difficult

Design Defect in Duoendoscopes Makes Sterilization Difficult


The U.S. Food and Drug Administration (FDA) issued a safety alert on Tuesday warning that  ERCP endoscopes, also known as duoendoscopes, may not be sterile because the complex design of the devices makes them difficult to process.

Duoendoscopes are flexible, lighted tubes that are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum). Contrast dye can be injected and other instruments can be inserted through a hollow chamber within the dueoendoscope to take tissue samples for biopsy or to treat certain anomalies. More Design Defect in Duoendoscopes Makes Sterilization Difficult and May Spread Drug-Resistant Infections, FDA Warns

Dangerous Labeling Issue Sparks Recall of Peripheral Infusion Systems

Labeling Issue Sparks Recall of Labeling Issue Sparks Recall

Labeling Issue Sparks Recall of Labeling Issue Sparks Recall


Covidien’s Trellis 8 and Trellis 6 Peripheral Infusion systems have been recalled due to a potentially dangerous labeling issue.

The Trellis 8 and Trellis 6 Peripheral Infusion systems are used to treat clots in the veins or arteries of the arms, hands, legs or feet. Two balloons that are housed in the systems inflate to isolate a clot, releasing medication between them to shrink the size of the clot or dissolve it so it can be removed, the U.S. Food and Drug Administration (FDA) explained in a recall notice posted on the agency’s website. More Dangerous Labeling Issue Sparks Recall of Peripheral Infusion Systems

Not all Implanted Medical Devices are Approved by the FDA

Not all Implanted Medical Devices are Approved by the FDA

Not all Implanted Medical Devices are Approved by the FDA


Some knee replacement devices implanted in patients have never been approved by the U.S. Food and Drug Administration (FDA). The OtisKnee implant, made by OtisMed Corp., demonstrates the problem with sending medical devices to the market with no human testing.

The OtisKnee uses magnetic resonance and three-dimensional software to direct the angle of the surgeon’s cuts so the artificial knee will be properly aligned. The guide is designed to help surgeons carve bone cuts that better fit a patient’s anatomy, according to The New York Times (The Times). More Not all Implanted Medical Devices are Approved by the FDA

Covidien Linked to Major Defendant in Pelvic Mesh Cases

Covidien Linked to Major Defendant in Pelvic Mesh Cases

Covidien Linked to Major Defendant in Pelvic Mesh Cases


Covidien, while not one of the large names of the vaginal mesh makers embroiled in the nearly 65,000 product liability lawsuits consolidated in a West Virginia federal court, the company is closely associated with one of the largest defendants, C.R. Bard.

Two Covidien subsidiaries manufacture and distribute pelvic mesh products to C.R. Bard. In fact, Covidien is named as one of the defendants in in the multidistrict litigation (MDL) against C.R. Bard. Covidien announced plans last summer to allocate $180 million from the firm’s third quarter profits to pay the costs associated with the cases – a decision that was made following discussions with plaintiffs’ attorneys over settlements. Covidien has promised to cover the losses, court documents show. More Covidien Linked to Major Defendant in Pelvic Mesh Cases

InterStim and InterStim II Flaw Could Force Patients to Undergo Surgery Prematurely

InterStim & InterStim II Flaw Could Force Patients to Surgery

InterStim & InterStim II Flaw Could Force Patients to Surgery


The Australian government and Medtronic Australasia issued a safety alert on January 28 concerning Medtronic’s InterStim and InterStim II neurostrimulation devices. The battery in the devices can fail prematurely.

In a safety alert posted on its website, the Australian Department of Health’s Therapeutic Goods Administration (TGA) warned that enabling the cycling feature in InterStim (model 3023) and InterStim II (model 3058) neurostimulation devices may lead to premature battery depletion, which can result in the patient having to undergo surgery sooner than expected to address the issue. More InterStim and InterStim II Flaw Could Force Patients to Undergo Surgery Prematurely