May 22, 2015 — Medtronic must stop most sales of its SynchroMed infusion pumps, after a decade of failing to correct problems linked to over a dozen patient deaths.
Medtronic has notified doctors of four potential defects with the pumps. All four issues were classified as Class I recalls, which means they could cause life-threatening injuries or deaths.
The FDA has filed a consent decree, a type of legal settlement in which a company agrees to court-ordered actions without admitting fault or guilt. Medtronic is banned from manufacturing, designing, and selling Synchromed implantable infusion pump systems except in very limited circumstances.
The first Synchromed infusion pump was approved in 2004. The first manufacturing problems were identified in 2006. Between 2006 and 2013, five inspections of manufacturing facilities resulted in three warning letters for “major violations.”
There are many examples:
- February 2011 — The FDA recalled the SynchroMed infusion pump after finding that doctors were accidentally injecting painkillers directly into patients instead of the pump. At least 270 people were injured and eight died from painkiller overdoses.
- September 2011 — The FDA issued a Class I recall for the SynchroMed pump after finding that the batteries could fail prematurely.
- August 2012 — The FDA issued a Warning Letter after receiving 567 complaints of corrosion, which could cause the motor to stall and fail to deliver medication. Medtronic knew about the issue in October 2007 but failed to fix problems.
- June 2013 — Bloomberg reported that 14 patient deaths had been linked to SynchroMed pumps since 1996, mostly involving over-doses or under-doses of medication.