FDA Recalls Integra LifeSciences Intracranial Medical Devices

Surgical procedures involving the brain can be very complicated.  A patient’s health, and in some cases, a patient’s survival, relies upon the proper functioning of medical devices used in conjunction with surgical procedures. Integra LifeSciences, a medical device manufacturer, issued a recall last month of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems.

The affected Integra medical devices are used to both drain cerebrospinal fluid as well as reduce pressure and swelling in the brain.  Patients diagnosed with hydrocephalus (“water on the brain”) may receive CSF shunts to help reduce the amount of fluid and pressure in the brain.  Some patients develop infected CSF shunts and require additional procedures with the use of devices like the LimiTorr and MoniTorr drainage and monitoring systems.

Medical Professionals Report Complications and Device Failures to Integra LifeSciences

Integra received multiple complaints from medical professionals indicating components of the medical devices were failing and/or not functioning properly.

Some of the complaints reported to Integra include, among others, the following:

• Piece breaking off at connection point;
• Broken manifold-stopcock;
• Stopcock problem;
• The connection where the external transducer is attached to the transducer holder bracket has broken off; and
• Transducer attachment on the LimiTorr and MoniTorr devices have cracked and leaked cerebrospinal fluid.

Any failure or malfunction of a key component of a medical device used in conjunction with intracranial procedures poses a serious risk of injury or death to patients.  As such, on May 24, 2019, the United States Food and Drug Administration (FDA) classified Integra’s recall as “class I,” which is the most serious classification possible and means that a drug or medical device poses a risk of serious injury or death to patients.

While no deaths have been reported to either Integra or the FDA that may be linked to the LimiTorr and MoniTorr devices, serious injuries have been reported.  The different types of injuries patients can suffer from include, but may not be limited to, the following:

• Infection (meningitis or ventriculitis);
• Fever;
• Headache;
• Over-drainage leading to subdural hematoma;
• Over-drainage leading to shifting of brain tissue (herniation);
• Backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity (pneumocephalus); and
• Death.

Integra did the right thing by voluntarily issuing a recall of all LimiTorr and MoniTorr devices that pose a risk of harm to patients.  However, device failures such as those reported to Integra should not happen in the first place.  While mistakes can happen, mistakes that place a patient’s health and safety at risk should be prevented by proper research and development, as well as careful manufacturing.  Whether a defect is linked to the design of a product or the way in which the product was manufactured, a medical device company with ample resources should test a device sufficiently to determine what potential failures can occur. Often, medical device companies are quick to get products on the market to reap the economic rewards, and unfortunately, patient safety sometimes comes second.

Contact Parker Waichman LLP Today to Schedule Your Free Consultation

If you sustained injuries from an intracranial medical procedure and believe an Integra product was used by your doctor or surgeon, you should consider speaking with a Defective Medical Device Lawyer right away who can evaluate your situation.  If you have a potential legal claim, you may be entitled to compensation.  At Parker Waichman LLP, our team of nationally-recognized trial attorneys handle complex defective medical device lawsuits on a regular basis and have helped many injured victims receive the compensation they deserve.  To find out whether you may have a valid legal claim, contact Parker Waichman LLP today by calling (800) YOUR-LAWYER (968-7529)to schedule your free consultation.

A National Law Firm With Offices In:
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation