What Are Some Examples of Defective Medical Devices?

J.P. Gonzalez-Sirgo
Founder of J.P. Gonzalez-Sirgo, P.A.

Miami and Florida Defective Medical Devices Attorney J.P. Gonzalez-Sirgo

Every year the Food and Drug Administration (FDA) receives hundreds of thousands of reports pertaining to defective, dangerous and malfunctioning medical devices.

  • These medical device defects result in countless injuries and deaths to unsuspecting patients and consumers
  • If you were injured by a defective medical device or product, or if a loved one lost their life, you may pursue compensation in a personal injury or wrongful death lawsuit

Compensatory damages are often significant when medical device manufacturers, designers and distributors negligently or knowingly place the public at risk with a defective, dangerous or malfunctioning product. Attorney J.P. Gonzalez-Sirgo has successfully represented thousands of clients in negligence and insurance cases since opening his law office in 1994. Attorney Gonzalez-Sirgo offers a free consultation to discuss your case.

Examples of Defective Medical Devices

The FDA lists thousands of defective and dangerous medical devices on its website. While some of these medical devices have been voluntarily recalled by the manufacturer, many have not. Why do medical device companies knowingly place their dangerous, defective products on the market? The most common reason: greed.

While some medical devices and products are relatively well known to the public, many lesser known ones, including device components and parts, are not.

Examples of defective medical devices include, but certainly are not limited to the following:

  • Knee implants
  • Hip implants
  • Joint implants
  • Pacemakers and ventricular assist devices
  • Heart valves
  • Cochlear ear implants
  • Stents
  • Transvaginal mesh products
  • Surgical instruments
  • Breast implants
  • Shoulder implants
  • Contaminated ultrasound gel
  • Improper labeling on diabetic blood glucose test strips
  • Defective blood glucose monitoring strips
  • Defective insulin delivery systems
  • Defective dialysis systems, resulting in blood flow impediment and blood clots
  • Ventilators that shut down without alarm or notice
  • Defective portable oxygen unit that may ignite and burst into flames
  • Anesthesia system defects and failures
  • Defective saline flush IV syringes - resulting in bloodstream contamination
  • Defective patient identification software results in misinformation and potential injury or death
  • Ventilator not delivering air for breathing
  • All others - please speak to Attorney Gonzalez-Sirgo about your particular case

Duty and Liability of Medical Device Companies

Medical device manufacturing companies have a duty to properly test their products and ensure they are safe for consumer use before placing them on the market. Numerous parties may potentially share liability for defective products, including the manufacturer, designer, importer, distributor and other pertinent parties.

The manufacturer must notify the FDA in the event of a reportable death, serious injury or malfunction. Hospitals, outpatient clinics, diagnostic centers and other facilities that utilize medical devices also have a duty to report malfunctions, injuries and deaths, as do distributors and importers.

Defective Medical Device Product Lawsuit

If an injury or death occurs as a result of a defective medical device, the victim(s) may pursue compensation in a defective medical product lawsuit, which may be based on the following:

  • Design defect – a flaw, miscalculation or other error in the product’s design
  • Manufacturing defect – a defect occurs during the manufacturing phase
  • Defect in marketing, instructions, warnings and/or information – failure to adequately convey instructions, dangers, risks or potential problems to consumer

Negligent parties may potentially face civil lawsuits and criminal prosecution. The government may use its seizure and injunction powers to protect the public from dangerous products.

Compensatory Damages for Victims of Defective Medical Devices in Miami, Ft. Lauderdale, Palm Beach and Throughout Florida

If you were injured by a defective medical device, you may potentially pursue compensation for past, present and future medical, hospital and rehabilitative expenses arising from the injury. Other damages may include pain and suffering, loss of enjoyment of life, lost income, lost future income, and more. Every case is unique and depends on its circumstances. Attorney Gonzalez-Sirgo will explain this to you.

Legal surviving heirs include the decedent's spouse, children, parents and others as proscribed by Florida’s Wrongful Death Statute 768.21. Compensation may include lost support and services, loss of companionship, mental pain and suffering, reimbursement for funeral expenses, if already paid, and more. The decedent’s estate may also pursue compensation for loss of net accumulations, lost earnings, medical and funeral expenses and more.

Damages for negligence and wrongful death are unique to each case and it is crucial to hire an attorney who has extensive experience and thoroughly understands how to pursue the maximum amount of compensation possible. Attorney Gonzalez-Sirgo and his team of attorneys at The Law Offices of J.P. Gonzalez-Sirgo, P.A., have successfully represented thousands of clients who were injured by the negligence of others as well as families of deceased victims.

There Are No Legal Fees Unless Attorney Gonzalez-Sirgo Wins or Settles Your Defective Medical Device Case

Attorney Gonzalez-Sirgo is a plaintiff’s attorney who zealously advocates on his clients’ behalf. He is there to protect your legal rights and to help you in your time of need. He will discuss your case with you and explain possible courses of action and potential outcomes in a free consultation.

The great majority of cases are settled with the defendant’s insurance company; only a small percentage of cases go to trial. Attorney Gonzalez-Sirgo and his team of attorneys will be fully prepared to take the case to trial if the defendant does not tender a satisfactory offer. It is worthy of note that if a manufacturer, distributor or other defendant knowingly placed a defective medical device on the market, resulting in harm or death, punitive damages are often successfully pursued.

There are no legal fees unless your defective medical device case is successfully resolved. 

You can reach Miami Personal Injury Defective Medical Device Lawyer J.P. Gonzalez-Sirgo by dialing his direct number at (786) 272-5841, calling the main office at (305) 461-1095, or Toll Free at 1 (866) 71-CLAIM or email Attorney Gonzalez-Sirgo directly at [email protected].


https://www.fda.gov/medicaldevices/safety/reportaproblem/ - FDA medical device reporting
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm - FDA medical device removal database – search for removed, recalled medical devices
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm359566.pdf - manufacturer reporting requirements
http://wayback.archive-it.org/7993/20170111083450/http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm384921.htm (recalls)
http://www.leg.state.fl.us/STATUTES/index.cfm?App_mode=Display_Statute&Search_String=&URL=0700-0799/0768/Sections/0768.21.html Florida Wrongful Death Statute