FDA Medical Device Recalls Skyrocket over Last 10 Years, Recent Report Indicates

FDA Medical Device Recalls Skyrocket over Last 10 Years, Recent Report Indicates


Posted June 16, 2014 by admin

Since 2003, the number of FDA medical device recalls that have been issued have increased by about 97 percent, a report from the FDA’s Center for Devices and Radiological Health (CDRH) has recently pointed out. The CDRH, which monitors medical device recalls through the Administration’s MAUDE (Manufacturer and User Facility Device Experience) database, has attributed this eye-opening increase in FDA medical device recalls to a number of different factors, including the facts that:

  • Medical device manufacturers (especially those that have been cited in the past) have demonstrated an enhanced awareness of potential defects and problems with their devices.
  • The CDRH has improved efforts to promote enhanced medical device safety. 
In the wake of a report that has shown a spike in FDA medical device recalls over the past decade, some are now questioning the FDA’s approval process for these devices.
In the wake of a report that has shown a spike in FDA medical device recalls over the past decade, some are now questioning the FDA’s approval process for these devices.

Additional Findings of the CDRH Report: Details of Recent FDA Medical Device Recalls

Some of the additional noteworthy findings of the CDRH report included that: 

  • The devices that were most frequently the subjects of these FDA recalls included ventilators, defibrillators and infusion pumps.
  • While the number of FDA medical device recalls increased, the average duration of the classification times for these high-risk recalls decreased (with Class I FDA medical device recalls decreasing by an average of 9 days and Class II recalls decreasing by an average of 26 days).
  • The most common reasons that FDA medical device recalls have been initiated over the past decade have been that recalled devices were made of problematic materials, were defectively designed, had software issues and/or had component issues.

While some FDA officials have tried to spin this report as being positive in that it allegedly shows an increased awareness towards improving the safety of medical devices, some critics have contended that the shocking rate at which FDA medical device recalls are increasing could highlight problems with the FDA approval process itself. 

Mount Vernon Product Liability Lawyers at the Law Firm of Hassakis & Hassakis, P.C.

If you’ve been injured after the use of a defective or dangerous medical device, it’s time to contact the Mount Vernon product liability lawyers at the law firm of Hassakis & Hassakis, P.C. Since 1950, our trusted attorneys have been providing client-centered representation to our Southern Illinois clients, focusing on their needs and doing everything we can to help them get the maximum possible compensation for their losses and injuries.

We take pride in tailoring our legal representation to specifically meet our clients’ needs and in expertly guiding them through each stage of the complex the legal process. While our attorneys are aggressive and effective litigators both inside and outside of the courtroom, we are also counselors that can provide our clients with helpful legal advice regarding their best options.

Contact Us Today for a Free Case Evaluation 

If you have been injured after using any defective product, contact us by calling (888) 896-9381 or by emailing us using the form at the upper right-hand side of the page. We can provide you with a free, thorough assessment of your case, along with professional advice regarding the best manner in which to move forward.

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