Even though medical device recalls have increased in recent years, the Food & Drug Administration (FDA) has not devised an effective process for notifying the public about dangerous devices. According to an Associated Press report, lack of such a process has put patients in danger.

In 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, and of those recalls, 100 were deemed Class I. A Class I recall is the FDA’s most serious recall, and is issued when there is a “reasonable probability of adverse health consequences or death.” But finding these recalled devices is no easy task, particularly after they have been implanted into someone’s body. (more…)

Approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs) are being recalled by Philips Healthcare. According to the recall notice, a potential memory chip failure may render the device inoperable.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy. (more…)

Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical situations.

This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued use of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury, or death. To date, there have been four injury reports, which may be potentially associated with this defect. (more…)

A report from the Food & Drug Administration (FDA) says the agency caved to political pressure when it approved ReGen Biologics Inc.’s Menaflex knee device. According to The Wall Street Journal, the FDA is now reconsidering its approval of Menaflex.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. Menaflex was approved through a process known as 510(K), which doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market. (more…)

The U.S. Food and Drug Administration (FDA) just announced it commissioned the Institute of Medicine (IOM) to study the pre-market notification program used to review and clear certain medical devices marketed in the United States.

The study will examine the program, also called the 510(k) process, for medical devices, which can be accessed here. The 510(k) process was established under the Medical Device Amendments of 1976 to ensure safe and effective devices are made available to consumers and to promote innovation in the medical device industry. (more…)

U.S. Health Regulators warned today that Philips Lifeline Personal Help Buttons can pose a choking hazard. According to a notice posted on the Food & Drug Administration (FDA) website, there have been at least six reports between 1998 and 2009 of serious injury or death, including three deaths in the United States and one in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck.

According to Philips Lifeline, the device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. By pushing the “help” button on the device when in distress, users can call for emergency assistance to their home. (more…)

Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we’ve reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and Medtronic Inc. has been under scrutiny.

Grassley’s probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance. (more…)

A prominent cardiologist with ties to Columbia University is facing questions regarding his ties to medical devices makers, the New York Times is reporting. According to the Times report, two U.S. Senators are concerned that Dr. Martin B. Leon may not have reported all payments he received from companies like Boston Scientific, Johnson & Johnson, Medtronic and the Volcano Corporation to Columbia.

According to the Times, Sens. Charles Grassley (R-Iowa) and Sen. Herbert Kohl (D-Wisc.) have been investigating Dr. Leon’s financial relationship with the medical device industry since last year. Last October, they sent letters to the Cardiovascular Research Foundation (CRF) and Columbia University regarding Dr. Leon and several other physicians. According to the Times, CRF sponsors an annual conference – the Transcatheter Cardiovascular conference – that has highlighted products developed by companies in which Dr. Leon and other CRF-affiliated doctors have financial stakes. (more…)

Physio-Control, Inc., a division of Medtronic, Inc., is recalling LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) has deemed this a Class I recall.

This recalled device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

According to the recall notice, an extremely humid environment may cause the LifePak CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

The recalled LifePak CR Plus AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. Devices with the following serial numbers are affected by this recall:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The Evenflo Co. did not properly investigate reports that its “Comfort Select” breast pumps caused some women to suffer electric shocks. In a warning letter dated August 25, the Food & Drug Administration (FDA) also said that during inspections earlier this year, several manufacturing violations were found at two Ohio plants that make the pumps.

According to the warning letter, the FDA said Evenflo received thirty-seven complaints involving breast pumps, but did not investigate 18 of them. Three complaints highlighted by the letter involved electric shocks. The FDA noted that Evenflo’s response to this and several other violations had been “adequate.”

An Evenflo official told The Wall Street Journal that the company does investigate its consumer complaints but said the problem was a “documentation issue.”

Another violation noted in the letter included the failure to verify or validate corrective and preventive actions to ensure that such actions were effective and would not adversely affect the finished device. The letter says that Evenflo’s response to this finding was only “partially adequate” because corrective actions did not extend to the Comfort Select pumps it sold prior to December 2008.

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The FDA also says the company still needs to develop medical device reporting procedures for its breast pumps that identify, evaluate and report complaints that might be subject to federal reporting requirements.

Evenflo had 15 working days from the date of the warning letter to notify the FDA of the specific steps the company has taken to correct the noted violations. Failure to do so could result in regulatory action being initiated by the FDA against Evenflo. Such actions include, but are not limited to, seizure, injunction, and/or civil money penalties.