|Medtronic is warning of potentially fatal flaws with its line of SynchroMed infusion pumps.--Courtesy of Medtronic|
Medtronic ($MDT) has issued four warnings over its SynchroMed infusion pumps, detailing problems that have attracted the FDA's most-serious label and led to 14 deaths over 17 years.
The company informed its customers this month of flaws that could put SynchroMed users in danger, including a problem with the device's bolus, a risk of electrical shorting, a faulty connector catheter and the potential for deadly refill error. Each correction has received a Class I recall tag from the FDA, a designation the agency reserves for problems that could cause serious injury or death.
As Medtronic told Bloomberg, 14 patients have died while using SynchroMed since 1996, with 11 deaths resulting from improper infusion, two from blockages and one from an electrical short.
Medtronic is working to rectify each of the issues, the company said in a statement, developing design updates to correct the bolus and shorting problems, updating its safety guidelines on refilling SynchroMed and recalling the catheter tied to blockages. The implantable infusion system remains on the market.
The company has been plagued by regulatory issues with SynchroMed for years, including an August FDA warning letter over manufacturing quality systems and an ongoing lawsuit brought on by a patient who claims the device left him paralyzed.
For whatever it's worth, Medtronic has been more forthcoming about the problems than most devicemakers in similar positions, issuing a news release detailing each warning instead of relying solely on the FDA's often sluggish public communication.
- read Medtronic's release
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