Medical Malpractice | InjuryBoard Philadelphia

At a recent European medical meeting, there were several reports about stent safety. Among the safety concerns was information showing increased risk of blood clots with the use of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent. Boston Scientific and Johnson & Johnson are the two biggest stent makers. Stents are used to keep arteries open after blockages are cleared in...

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A supply of Alaris infusion pumps, worth approximately 1.8 million dollars, was seized by United States Marshals. The seizure involved several models of Alaris infusion pumps, and took place at the company's manufacturing plant in San Diego, California. A design defect called "key bounce" could cause the infusion pumps to deliver an over-infusion of medication, which may result in injury or...

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The FDA has issued a Class 1 recall of Welch Allyn PIC 50 Automated External Defibrillators, manufactured between March 2002 and October 2004. The device may delay or fail to resuscitate the patient. This failure is caused by an eletrical contact problem. During this failure, the device may display various error messages including the "Defib Comm" message.

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Baxter Healthcare Corp. (Baxter) has stopped production and distribution of its Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until manufacturing deficiencies are corrected. This action was announced by the FDA and was part of a consent decree signed by Baxter and its CEO and Corporate Vice President. Patients use infusion pumps to control delivery of...

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Boston Scientific has announced a safety alert regarding some of its pacemakers and cardiac defibrillators. "The specific subset of devices includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, AND VITALITY 2 implantable cardioverter defibrillators." An identified issue with a low-voltage capacitor may cause loss of...

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MRL, a division of Welch Allyn, is recalling about 500 of its model AED20 automatic external defibrillators. A faulty electrical connection could cause the device to malfunction and fail to resuscitate patients. For all customers of the recalled defibrillators, MRL will pay the costs to ship and replace the defective component. The FDA has determined that this action is a Class I recall,...

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Boston Scientific recently announced a new defect in Guidant heart defibrillators that may cause the devices to quit prematurely. The battery failure is due to a defective low-voltage capacitor. According to the company, the problem affects the following models: Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and Contak Renewal 4 AVT. The capacitor in question came from a...

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The Heart Rhythm Society, a group of electrophysiologists, has drafted some guidelines regarding pacemakers and implantable defibrillators. The guidelines were drafted after the society, FDA representatives and industry representatives participated in a two-day meeting last September. Included in the guidelines are recommendations for independent watchdog committees to monitor manufacturing...

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Boca Medical Products voluntarily recalled some of its insulin syringes because of possible bacterial contamination. A contaminated syringe poses a risk of local infection and also introduction of bacteria into a sterile vial of insulin. The specific syringe is Ultilet Insulin Syringe 30g 1/2cc (Lot # 5GEXI, NDC# - 08326-3002-50). The syringes were distributed in the following states: AL, AR,...

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Newly released documents demonstrate turmoil inside Guidant Corporation while its heart devices came under scrutiny last year. The records include e-mail messages, transcripts, memos and notes. While Guidant's public message was upbeat and positive, the company's executives and sales representatives were alarmed about the scrutiny of defects in its defibrillators and pacemakers, and the company...

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Boston Scientific is recalling one of its medical devices. The Flextome Cutting Balloon system is used to open blocked arteries or blood vessels. The FDA and Boston Scientific recently recalled the device because one of its parts may separate when the device is withdrawn from the patient. More in-depth surgery may then be required to remove the piece from the artery. Boston Scientific...

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After Guidant Corporation appeared ready to give its full support to latest bid from Johnson and Johnson, Boston Scientific raised its bid for Guidant, with help from Abbott Laboratories. The new offer, at $80 a share, quickly got Guidant to switch its support from the Johnson and Johnson proposal to Boston Scientific. The two companies have recently been in a bidding war for Guidant, which...

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The FDA and Ortho Clinical Diagnostics notified health care professionals of the recall of a blood testing kit. The HBsAg Confirmatory Kit is used to test blood for the Hepatitis B virus. An unknown component in the diluting solution may produce Not Confirmed results for samples found to be positive with the initial test. These false negative results could result in a lack of treatment for...

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Guidant Corporation recently received more bleak news from the FDA. Citing concerns about the manufacturing practices of the company, the FDA informed Guidant that it would not approve any more company devices for sale, nor will the FDA approve new contracts to export Guidant heart devices manufactured in its Minnesota plant.This news comes at a time when the company is still reeling from...

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Mentor Corp., a maker of silicone gel breast implants, is hoping for FDA approval to sell its implants for general cosmetic use. However, the implants have exhibited a problem of leaking silicone oil. A former engineer for Mentor told the FDA that when the company was alerted to the problem, it fixed the demonstration models of the implants that would be used in doctor offices, but not the...

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