Faulty Medical Devices

Medical devices regulated by the FDA range from low-tech tongue depressors to complex pacemakers with microchip technology.

In addition to initial approval, the FDA also oversees product recalls of medical devices. While recalls help the general public, patients already using a problematic device may already have been harmed by the time they learn of the device recall.

Federal law requires FDA regulation, including pre- and post-marketing guidelines, for medical devices intended to diagnose, treat, or prevent a given malady. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article …” that works by actions other than chemical or metabolic.

“If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug,” according to the FDA’s Overview of Device Regulation [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm].

Medical devices are classified into Class I, II, and III, with regulatory control increasing from Class I to Class III.

Most often, companies voluntarily recall problematic medical devices. However, the FDA can initiate action if a company fails to do so.

For medical devices, a recall doesn’t necessarily require a person to stop using a product. Other types of recall action could include: inspecting the device for problems; repairing the device; or re-labeling the device.

However, if the device is dangerous, the recall happens only after people have been killed or injured.

Some examples of faulty medical devices recalled by the FDA:

  • Stryker Hip Implant Recall
  • Medtronic Infuse Bone Graft
  • Composix Kugel Mesh Patch
  • DePuy Hip Replacement
  • DePuy Pinnacle Hip Implants
  • Fire Star RX and Dura Star RX PTCA Balloon
  • SimplyThick
  • Transvaginal Mesh