Medtronic Inc.’s (NYSE:MDT) Class I recall for the SynchroMed II implantable drug infusion pumps won’t be a bit hit to the med-tech giant’s bottom line, according to Morningstar analysts.
The recall, the second Class I for SynchroMed this year, came over concerns of defective batteries that can lead to sudden device failure.
The SynchroMed system includes an implanted catheter and pump infusion system that stores and delivers medication to a specific site. There are about 140,000 pumps in use worldwide.
While the recall was classed in the highest risk category, reserved for situations with a reasonable probability of serious adverse consequences or death, the recall won’t have a big impact on Medtronic, according to Morningstar analyst Debbie Wang.
“Anytime you get one of these recalls, it’s a little nerve-wracking because you wonder if it’s a signal if this company is slipping and cutting corners or not paying close enough attention on quality,” Wang told the Star Tribune. “I don’t see any indication of that yet with Medtronic, but it’s a question that I ask.”
“The FDA has approved a battery design change intended to prevent the issue from occurring in new pumps, and all SynchroMed II pumps are being manufactured with the new battery,” Medtronic spokesperson Cindy Resman told MassDevice. “This design change has already been implemented in several global regions and is in the process of being implemented in the rest.”
The SynchroMed II device went through its first recall in February over the potential for “pocket fills,” which occur when drugs are unintentionally injected into the tissue where the pump is implanted rather than at the desired site.
The battery problem arose even earlier, first noted in a July 2009 letter to physicians. Medtronic provided an update last month with no recall planned and recommending the devices not be surgically removed unless there were battery issues observed.