Infusion Pump Recall - Consumer Justice Foundation

Infusion Pump Recall

Written by Faith Anderson on December 27, 2012
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Infusion Pumps Have High Failure Rate

In response to Medtronic’s concerns, the FDA has declared a Class I recall of the Medtronic SynchroMed Infusion Pump, although the potentially dangerous medical devices remain on the market available for continued use. Class I recalls are the most serious recall classification issued by the FDA, and indicate that the agency believes the devices could cause severe injury or possibly even death. According to Medtronic, the typical failure rate of its SynchroMed model fusion pumps is 2.4% after 6.5 years of use. However, when unapproved drugs are used in the devices, the failure rate increases to 7%. Drugs approved for use in the SynchroMed infusion pumps include Floxuridine, Infumorp, Prialt, Lioresal, Gablofen and Methotrexate.

FDA Warnings for Potential Side Effects

In July 2012, the FDA sent a warning letter to the medical device firm over its SynchroMed infusion pumps, ordering the company to establish a plan to deal with reported device failures. According to the letter, between October 2007 and July 2012, the FDA had received an alarming 567 complaints about motor corrosion problems affecting the SynchroMed II pump. The unexpected corrosion reportedly caused gears to lose teeth, which resulted in the motor seizing up. With this new warning, the FDA and Medtronic are warning customers against using any compounded medications, unapproved formulations or unapproved concentrations with the fusion pumps to reduce the risk of device failure.

Contact an Experienced Attorney for Help

The SynchroMed Infusion Pumps manufactured by Medtronic have been plagued by numerous problems over the past couple of years. In February 2011, the FDA issued a Class I recall for SynchroMed pumps following reports that physicians were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the medical devices. These so-called “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical attention. In September 2011, a Class I recall was issued for the SynchroMed battery after the company received reports of batteries becoming covered with a thin film, causing them to fail. If you believe you have been adversely affected by a recalled SynchroMed infusion pump, contact an experienced attorney in your area for legal help.

Posted Under: FDA - Food and Drug Administration
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