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Medtronic Shunt Recall

Medtronic Shunt Recall Side Effects May Lead To Hydrocephalus Lawsuits

Medtronic Shunt Recall | Lawsuits, Lawyers | Side Effects: Hydrocephalus, Accumulation of Fluid In Brain | Defective Part Dislodged In Brain, Recall, Faulty Medical Device

The lawyers and attorneys at our firm are offering free consultations to anyone who was injured as a result of defective BioGlide Ventricular Shunt Catheters made by Medtronic Inc. These defective medical devices were subject to a Class I recall in 2009.

A Class I recall is the Food & Drug Administration's (FDA) most serious safety alert. This means that malfunctions of the recalled Medtronic BioGlide Ventricular Shunt Catheters could lead to serious injury or death. Our Medtronic BioGlide Ventricular Shunt Catheter injury lawyers believe these devices pose a significant risk to the patients who have received them.

The defective Medtronic BioGlide Ventricular Shunt Catheters, which are often used in children, were recalled because a piece can dislodge and remain in the skull. At the time of the recall, Medtronic said there had been nine reports of such an occurrence. However, not all adverse events are always reported, and our Medtronic BioGlide Ventricular Shunt Catheter injury lawyers believe these defective devices may have harmed many more patients.

If you or someone you love were injured as a result of a defective Medtronic BioGlide Ventricular Shunt Catheter, you may be entitled to compensation. We urge you to contact one of our Medtronic BioGlide Ventricular Shunt Catheter lawyers right away to protect your legal rights.

Medtronic BioGlide Ventricular Shunt Catheter Recall

The recalled Medtronic BioGlide Ventricular Shunt Catheter is part of a system used to treat a condition called hydrocephalus, which is characterized by an excessive accumulation of fluid in the brain that can occur in both adults and children. Experts estimate that hydrocephalus affects approximately one in every 500 children.

Medtronic initially recalled the defective shunt catheters in February 2009. However, it wasn't until March 27, 2009 that the FDA announced it had given the recall Class I

In February 2009, Medtronic sent their customers a recall notice informing them that they:

  • should stop using the device,
  • need to return all unused products to the company,
  • are required to account for each used (implanted) device, and
  • are to advise surgeons about the recall.

The recalled Medtronic BioGlide Ventricular Shunt Catheters were manufactured from October, 2002 through December, 2008 and distributed from April 29, 2004 through December 12, 2008. They were sold in the U.S., Australia and Asia.

The recall involves the following models:

  • Innervision Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27782
  • Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27802
  • Snap Shunt Ventricular Catheter, BioGlide Catalog Number 27708

According to the recall notice, the ventricular catheter may become detached from the snap base assembly after implantation. This may increase the need for emergency corrective surgery. This is a painful and traumatic experience for any patient, but can be even worse for children, the most likely recipients of Medtronic's faulty BioGlide Ventricular Shunt Catheters.

If a disconnection occurs, patients may present with a return of the symptoms of hydrocephalus. Symptoms of a shunt catheter malfunction include nausea, vomiting, headache, lethargy, a change in "mental status," seizures and visual disturbances.

Medtronic's recall notice said patients with the implanted shunt system not experiencing symptoms of shunt malfunction should continue to be managed under the standard patient management protocols. Patients with questions are encouraged to talk with their physician or contact Medtronic Neurosurgery at 1-805-571-8400, Monday – Friday, 8 a.m. to 5 p.m. CDT.

Medtronic said about 3,000 of the catheters were distributed between the product's launch in October 2002 and this year. Approximately 2,500 to 2,700 were implanted in patients. It is estimated that there are 300 unused catheters in circulation.

Legal Help for Victims of the Medtronic BioGlide Ventricular Shunt Catheter

Our Medtronic BioGlide Ventricular Shunt Catheter injury lawyers are currently evaluating potential lawsuits on behalf of anyone injured as a result of this defective device. If you or someone you know suffered as a result of a malfunctioning Medtronic BioGlide Ventricular Shunt Catheter, you have valuable legal rights. Please fill out our online form, or call 1-800 YOURLAWYER (1-800-968-7529) to discuss your case with one of the experienced Medtronic BioGlide Ventricular Shunt Catheter injury lawyers at our firm.



 

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Dec 10, 2009 | Parker Waichman LLP
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Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Nov 19, 2009 | Parker Waichman LLP
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...

Grassley Putting More Heat on Spine Surgeon with Medtronic Ties

Sep 23, 2009 | Parker Waichman LLP
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...

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