Medical Malpractice

• New Warning About Defect In Guidant Heart Devices

  Jamie Sheller | May 17, 2006 8:33 AM | 0 CommentsPhiladelphia, PA

  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...

• New Guidelines Recommended For Heart Device Industry

  Jamie Sheller | April 27, 2006 11:07 AM | 0 CommentsPhiladelphia, PA

  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...

• Ultilet Insulin Syringe Recalled

  Jamie Sheller | April 19, 2006 10:15 AM | 0 CommentsPhiladelphia, PA

  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,...

• Guidant Faced Internal Turmoil Over Defective Heart Devices

  Jamie Sheller | February 28, 2006 9:54 AM | 0 CommentsPhiladelphia, PA

  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...

• Safety Alert for Blood Testing Kit

  Jamie Sheller | January 16, 2006 7:44 AM | 0 CommentsPhiladelphia, PA

  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...

• More Trouble for Heart Device Manufacturer

  Jamie Sheller | January 03, 2006 8:37 AM | 0 CommentsPhiladelphia, PA

  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...

• Incomplete Fix for Silicone Gel Implants

  Jamie Sheller | December 16, 2005 9:20 AM | 0 CommentsPhiladelphia, PA

  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...

• Guidant, Medtronic & St. Jude Devices Earn Subpoenas

  Jamie Sheller | November 16, 2005 8:23 AM | 0 CommentsPhiladelphia, PA

  Guidant Corporation, Medtronic and St. Jude Medical, three big makers of implantable heart devices, acknowledged receiving subpoenas from the United States Department of Justice. Apparently, the Justice Department has launched an investigation into possible violations of federal anti-fraud and anti-kickback statutes. Such violations could involve giving illegal payments or other benefits to...