Report: St. Jude sold off older CRM devices after learning of battery issue

St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune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 in 2015 over issues with batteries failing with little to no warning, an issue which resulted in 2 deaths, 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 fro...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Recalls St. Jude Medical Source Type: news