Medtronic Defibrillators
Medtronic Recall
On October 15, 2007, Medtronic immediately suspended sales of the Sprint Fidelis electrical wire following reports of connection failure. Medtronic noted that failed lead wires caused by a fracture in a sense conductor or coil may have contributed to the death of at least 5 heart patients. It is estimated that nearly 230,000 patients still have the potentially defective device in their bodies.
Device recalls are nothing new for Medtronic. On February 3, 2005, Medtronic announced the recall of several models of it’s implanted defibrillators. The devices were recalled because they are prone to battery shortages which can cause them to fail, presenting a life-threatening situation. The battery problem affects Medtronic’s Marquis line, which includes the brand names Marquis, Maximo and InSynch. Medtronic is alerting recipients of defects in the following defibrillator models:
- Sprint Fidelis Electrical Wire
- Micro Jewel II Model 7223Cx
- GEM DR Model 7271 implanted cardioverter-defibrillators
- 7230 Marquis VR
- 7274 Marquis DR
- 7232 Maximo VR
- 7278 Maximo DR
- 7277 InSync Marquis
- 7289 InSync II Marquis
- 7279 InSync III Marquis
Medtronic Catheter Recalls:
- Model 8731 Intrathecal Catheter (July 2006)
- Model 8598 Intrathecal Catheter Distill Revision Kit (July 2006)
On April 16, 2004, Medtronic recalled two other defibrillator models because they were delivering an electrical pulse too slowly. The recall includes Micro Jewel II Model 7223Cx and GEM DR Model 7271 ICDs. 6,268 of these devices were manufactured, of which an estimated 1,800 are thought to be still implanted in patients worldwide. One serious injury and four deaths have been related to defects in the Micro Jewel II devices.
On February 23, 2005, Medtronic announced a recall of it’s Lifepak 500 automated external defibrillators. These devices may fail to analyze the patient’s heart rhythm even when the electrodes are properly connected and the device appears to be working correctly. The recall affects 1,924 Lifepak 500 devices, all of which were manufactured in 1997.
The Lifepak 500 is used by first responders such as firefighters and police officers who are first to arrive at the scene of a cardiac incident but do not have significant medical training. To date, there have been 54 incidents regarding this group of defibrillators including eight cases where it may have prevented patient resuscitation.
All three of these recalls are considered Class I by the FDA, meaning there is reasonable probability that the continued use of the devices will cause serious adverse health consequences or death.
If you or a loved one have experienced any major side effects as a result of a defective Medtronic Defibrillator, please call us at (800) 966-4999 or fill out our online contact form for a free case evaluation.
