Defective Medical Devices | InjuryBoard Philadelphia

Is it safer to be in the hospital during the day when having a heart attack than in the evening? According to recent research, a higher percentage of heart attack patients get better care during the day at a hospital, than between the hours of 11 pm and 6 am. Apparently, hospitals are better staffed and more attentive to patient needs during the day. Sadly, those who rely upon the staff the...

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Postarthroscopic Glenohumeral Chondrolysis, or PAGCL, is a painful condition in the shoulder caused when the cartilage between the humeral head and the ball and socket of your shoulder has broken down to the point where bone meets bone. Recently, studies have shown that pain pumps used after shoulder surgery is a leading cause for this pain. While these products are still available on the...

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Thoratec Corporation has recalled its Implantable Ventricular Assist Devices (IVAD) catalog number 10012-2555-001, serial numbers 488 or higher. The recalled devices were manufactured and distributed from October 1,2 004 through October 22, 2007. These IVAD's are used to help pump blood through the body of a person whose body is too weak to perform that function. The IVAD can be implanted or...

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Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...

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Medtronic has removed its Sprint Fidelis defibrillation leads from the market after several adverse events in patients. Defibrillators are used to monitor the heart rate in patients. If the defibrillator detects an irregular heart rhythm, it sends an electrical shock to the heart to restore normal rhythm. Medtronic has found that the leads are prone to fracture. These fractures may cause the...

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Due to a defect causing shortened battery life, Guidant has recalled several models of its implantable cardiac defibrillators (ICD's) and cardiac resynchronization therapy defibrillators (CRT-D's). The recall involves about 73,000 devices, which have faulty capacitors possibly leading to rapid battery depletion. The Guidant ICD's and CRT-D's included in this recall are the Contak Renewal 3 HE...

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Recently, the FDA updated an earlier public health advisory concerning gadolinium-based contrast agents used with MRI and MR angiography procedures. There have been a number of reports of a new disease called nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NSD) occuring in patients with moderate to end-stage kidney disease. Some patients developed NSF/NSD after only one...

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The FDA has recalled 12 lots of Boston Scientific's Mach 1 Guide Catheters. These devices are tubes that are thread through the body and used to help treat coronary artery disease. Excess strands of resin may be inside of some of the catheters. In the event that excess resin is present and detaches while the catheter is being used in treatment, embolization may occur. Embolization in a blood...

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According to the FDA, off-label use of drug-eluting stents carries an increased risk of thrombosis, myocardial infarction and death. An FDA advisory panel recommended changing the labels of such stents. The two approved devices are Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting). Approximately 60% of the three million drug-eluting stents implanted in Americans, are off-label. In...

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Recently, Roche Diagnostics issued a recall of CoaguCheck PT test strips. Patients using anticoagulants or blood thinners have their blood tested to determine clotting time. The strips are used for that purpose, both by patients at home and by medical professionals. Depending on the blood clotting time, corrective measures may need to be taken. A defect in the CoaguCheck PT strips may cause...

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Recently, the Guidant Corporation settled a lawsuit over one of its cardiac defibrillators. The fraud suit was filed in Texas, and trial was scheduled to start on September 18, 2006. In the lawsuit, plaintiffs Beatrice Hinojosa and Louis Motal claimed that Guidant failed to warn them about the risk of failure for their implanted heart devices. In 2005, Guidant recalled thousands of its...

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AbioCor, a fully implantable mechanical heart manufactured by Abiomed, Inc., gained FDA approval for very limited use. "Only patients who have advanced heart failure that has affected the left and right ventricles and who are not candidates for a heart transplant will be eligible to receive the device under the agency's Humanitarian Use Device provisions." The mechanical heart is powered by a...

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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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