Contact Us

PW Case Review Form
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

   * Please describe your case:

What injury have you suffered?

For verification purposes, please answer the below question:
+
=

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

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.



 

Medtronic Shunt RecallRSS Feed

Medtronic Issues Voluntary Recall of StrataMR Valve

Apr 11, 2017
Medtronic has announced a worldwide recall of an implantable medical device called the StrataMR. The device is used to relieve fluid pressure from the brain by gradually relieving intracranial pressure from a condition called hydrocephalus. This is a condition when a patient has an abnormal buildup of cerebrospinal fluid in the brain. The device is a valve used to control the flow of fluid from the brain, but complaints, including a patient death, has prompted the voluntary recall, the Star...

Medtronic StrataMR Valves and Shunts Recalled Due to Adverse Events

Mar 22, 2017
Medtronic StrataMR Neurological Devices Recalled Medtronic is recalling its StrataMR adjustable valves and shunts this month, the company said in an Urgent Field Safety Notice. The voluntary recall, which affects all unused units, is being issued due to problems with flow resistance; this can cause under drainage of cerebrospinal fluid. The Medtronic StrataMR valves and shunts are neurological devices used to treat hydrocephalus, a condition where there is a buildup of cerebrospinal fluid...

Medtronic Announces Layoffs, as Infuse Controversies Drag Down Sales

Sep 28, 2012 | Parker Waichman LLP
Medtronic announced in May it would be cutting some 1,000 jobs, as the controversy surrounding its Infuse Bone Graft product continues to weigh on the medical device maker’s bottom line.  "We are eliminating about 1,000 positions around the company and around the globe," Gary Ellis, the company's chief financial officer, told the Minneapolis Star Tribune at the time. "It's kind of the normal, ongoing thing that goes forward as we shift resources from slower-growing markets to ...

Medtronic Unit Settles Defective Spine Device Lawsuit

Apr 29, 2011 | Parker Waichman LLP
A lawsuit involving the Danek 3-D TSRH Spinal System made by a unit of Medtronic Inc.  has been settled, according to a report from Law360.   The lawsuit was brought by a Puerto Rican woman and her family who claimed the Danek 3-D TSRH Spinal System caused her to suffer serious and life threatening injuries.According to Law360, the Danek 3-D TSRH Spinal was recalled by the U.S. Food & Drug Administration (FDA) because of a manufacturing defect that could cause the implant to...

Medtronic Says California Seeking Info on Heart Rhythm Devices

Dec 10, 2009 | Parker Waichman LLP
Medtronic Inc. is being investigated in California over its heart rhythm devices.  According to The Wall Street Journal, Medtronic recently disclosed that it had received a subpoena from the Department of Health and Human Services' Office of Inspector General in California.Medtronic reported the subpoena in a quarterly filing with the Securities and Exchange Commission (SEC) it had made on Wednesday.  The disclosure read as follows: "On September 16, 2009, the Company received a...

More Medtronic Shunt Recall News

Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo