Updated: Corrected date of recall from 2015 to October 2016.
St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report.
The devices were recalled last month over issues with batteries failing with little to no warning, an issue which resulted in 2 deaths and was discovered by the company, according to the report. Despite fixing the problem and producing new, updated units, St. Jude continued to distribute the older devices indicated in the recall for 17 months.
Executives at St. Jude reportedly “moved as quickly as possible with the information they had about the battery problem,” which was 1st revealed in a journal article in 2014, according to the report. But the company acknowledged it continued to ship its stock of old devices that could potentially have the battery fault for over a year after upgrading its design.
“If we had known, or the [St. Jude] Medical Advisory Board had known in 2015 what we know in 2016, I’m sure that their advice and our actions would have been very different,” St. Jude chief medical officer Dr. Mark Carlson said, according to the report.
The recall now affects nearly 400,000 people implanted with the affected devices, which St. Jude identified in a warning issued in early October.
The Little Canada, Minn.-based company warned of the possibility that a battery issue could disable its high-voltage cardiac rhythm management devices. The problem stems from a risk that the lithium-based batteries used in its implantable cardioverter defibrillators and cardiac resynchronization therapy devices could form “lithium clusters” during high-voltage charging. The clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy. Dr. Carlson said most patients won’t require prophylactic replacement “because the risk associated with replacing the devices outweighs the low risk of a patient problem occurring.”
The FDA and St. Jude recommended that patients with the older batteries undergo home monitoring to avoid failures, and all patients should seek immediate care if they feel the vibratory alarm within their chest as it may signal a fully depleted battery in less than 24 hours, according to the report.
Last week, St. Jude Medical said it paused implantations of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting.
The company said it pulled implants of the micro-sized, catheter-delivered Nanostim after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there have been no reports of patient injuries associated with the malfunction.