Personal Injury Law

Dangerous Medical Device Recalls ? Medtronic and the FDA

Medtronic, the medical device manufacturer, has had many of its medical products subject to a flurry of Class I recalls and warnings in recent months. These include Medtronic catheters, defibrillators, and pacemakers being issued the FDA most severe warnings for defects that may cause potentially severe injuries.

Medtronic?s Sutureless Connector intrathecal catheters (SC catheters) were recalled for labeling errors that have already negatively affected 10 patients when, per company instructions, the catheter was used with the Medtronic IsoMed Pump Model 8472, a constant-flow infusion drug pump Medtronic discontinued last year as part of a "planned product phase-out." What some might see as a minor oversight in printing--unless you?re one of the nine patients depending on the pumps? cancer-fighting drugs whose catheters became disconnected and who required surgery to correct the problem, especially if you?re one of the nine who died two days following the procedure.

Full post as published by Tennessee Law Blog on September 18, 2009 (boomark / email).