Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).

According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter. (more…)

Cardiovascular Systems Inc. (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical. According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device. The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. (more…)

The use of Negative Pressure Wound Therapy systems have been associated with deaths and serious complications, the U.S. Food & Drug Administration (FDA) warned yesterday. In a health alert posted on its Web site, the FDA said it will continue to monitor adverse events associated with Negative Pressure Wound Therapy systems, and will make available any new information that might affect their use.

Negative Pressure Wound Therapy helps various types of open wounds heal by creating a negative pressure (vacuum) at a well-sealed wound site. The vacuum helps remove fluids and infectious materials and draw wound edges together. Negative Pressure Wound Therapy is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature. (more…)

Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device. The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.

The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation. (more…)

The U.S. Food and Drug Administration (FDA) is looking into whether or not revised regulations are called for regarding how information is delivered on medicines and medical devices via the Internet, says Reuters. The meeting is entitled “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media,” and was announced in September.

Companies and consumer groups will be voicing opinions in a two-day meeting that began today. The focus of the meeting is on if Internet drug advertising requires “special oversight,” said Reuters. To start, the Pharmaceutical Research and Manufacturers of America, an industry group, is working to have the FDA agree to a safety logo that would appear on Internet information and would also be linked to FDA-approved information about the device or medication, said Reuters. (more…)

The U.S. Food and Drug Administration (FDA) is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. The agency indicated that it has received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion.

The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia, as well. FDA is seeking additional information in order to interpret the significance of these events, and to determine if agency activities are advised. (more…)

Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter. The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall.

The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. According to the recall notice, the balloon catheters may spontaneously rupture during surgery. (more…)

Last year we wrote that a prominent physician from the Minneapolis Heart Institute Foundation had expressed concern about test guidelines for a next-generation heart defibrillator under development at the time by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc. Now, Bloomberg News is reporting that Boston Scientific has agreed to pay nearly $300 million to settle an investigation conducted by the U.S. Justice Department on the medical device maker’s Guidant unit and how it handled cardiac devices and manipulation of third-quarter financial results.

Boston Scientific is planning on paying $296 million—approximately one-fifth of its “cash on hand”—and Guidant is planning on pleading to two criminal misdemeanors, said Bloomberg News. The misdemeanors involve not appropriately advising the U.S. Food and Drug Administration (FDA) regarding issues concerning some of its implantable cardioverter defibrillators (ICDs), according to Bloomberg News. Apparently, the investigation involved some advisories that Guidant distributed on its product prior to being acquired by Boston Scientific, said Bloomberg News. The acquisition took place in April 2006. (more…)

Three more lawsuits have been filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted with defective defibrillators made by the device maker, according to the Madison Record.

The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. “Electrodes that sense the heart’s rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous ‘overdrive pace,’ a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected,” the suit states, quoted the Madison Record. (more…)

Centurion Medical Products Premie Pack and Meconium Pack Pediatric Tracheal Tubes have been recalled, the U.S. Food and Drug Administration (FDA) just announced. The tubes were manufactured with an internal diameter smaller than that indicated on label.

The recall has been directed to anesthesiology healthcare professionals and hospital risk managers and both Centurion Medical Products and the FDA have notified healthcare professionals about the Class I recall that involves Premie Pack, Kit Code LM 110 and Full-Term Meconium Pack, Kit Code LM115. Class 1 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. (more…)