FOIAengine: How FOIA Requests Pointed to Problems at Boston Scientific
Months before Boston Scientific expanded its urgent warning this month about the risk of sudden death from its Accolade pacemakers, something quieter was happening inside the U.S. Food and Drug Administration: a steady drip of Freedom of Information Act requests, all pointing to the same place — a sprawling, low-slung corporate campus in Arden Hills, Minnesota.
Our review of the latest FDA FOIA logs shows that, beginning in early 2025, requesters began zeroing in on Boston Scientific’s operations at its Arden campus, located in a suburb of St. Paul, Minnesota. The FOIA requesters were seeking inspection reports, warning letters, and manufacturing records. On their face, the multiple FOIA requests seemed routine, more like fishing expeditions; they didn’t name a defect.
But taken together, the requests formed a pattern — one that, in retrospect, traced a regulatory trail that would later reveal unexpectedly high pacemaker battery failure rates, jeopardizing the lives of 1.6 million recipients of Boston Scientific’s pacemakers.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, the FOIA requests to the FDA grew more specific over time – in essence, signals that increased in intensity until they beamed solidly toward potentially fatal patient outcomes and litigation to come.
The early signals were subtle. Initially, FOIA requests targeting Boston Scientific circled the company’s cardiac devices more broadly, seeking premarket approval applications, supplemental filings, and correspondence with regulators. For example, a May 2023 request from the mass-tort law firm Foster Law sought “copies of all FDA Form 483s, EIRs (Establishment Inspection Reports) and inspection records” related to the Arden Hills facility, as well FDA correspondence regarding premarket authorization for defibrillator software.
But the FOIA requests targeting Boston Scientific grew more precise over time, particularly after the company issued its first of several warnings about the Accolade pacemaker in December 2024.
Within months, FDA inspectors showed up at the Minnesota site. By the following spring and summer, FOIA requesters – including multiple people within Boston Scientific, itself a frequent FOIA requester – were seeking the paper trail those inspections left behind.
A May 2025 request from Redica Systems sought “all Form 483 observations and Establishment Inspection Reports” for Boston Scientific’s Arden Hills facility. The following month, Mike Williams, a prolific requester from Capitol Forum, made a similar request. In August, Elizabeth Koh, an investigative reporter on the Boston Globe’s Spotlight team, sought “any and all records, reports, memoranda, correspondence, emails, transcripts, notes, and any other documents relating to enforcement actions, investigations, inquiries, or complaints concerning Boston Scientific Corporation.”
But it was a January 14, 2026 FOIA request by Katie Thomas, a health care investigative reporter for the New York Times, that pointed to the issues to come.
Thomas’ FOIA request stood apart in its precision, seeking premarket approval documents tied to individual pacemaker models and identifying specific filings by Boston Scientific.
Thomas’ request focused not just on the Accolade model, but also on earlier models – Essentio, Proponent, and Altrua – that had been the subject of a previous urgent recall.
Her FOIA request aligned with the reporting that followed, two months later. Boston Scientific’s problems were finally coming into full public view.
The problem with the Accolade pacemaker had to do with its battery life. Thomas’ March 19 New York Times story revealed that, “for years, factory tests had revealed pacemaker batteries that were failing unexpectedly, according to internal company records and government inspection documents.
“But the problem is far broader. Last spring, inspectors from the Food and Drug Administration found that a pacemaker battery made more recently had also failed, according to a report that has not previously been made public. And company documents reviewed by the Times show that dozens of test batteries made between 2019 and 2023 did not work properly after they were subjected to conditions similar to those that had caused pacemakers to falter in the real world.”
The Times story said the Boston Scientific pacemakers – the Accolade model as well as a different line, called Ingenio, that was the subject of a 2021 recall – were linked to at least seven deaths and more than 800 injuries. Previously, Boston Scientific had said the issue was limited to 13 percent of its pacemakers on the market — about 200,000 devices that were made before September 2018.
Only after Thomas’ FOIA request and last week’s resultant story — and as evidence of battery-related failures mounted — did Boston Scientific expand its safety actions, ultimately widening its advisory to cover a far larger population of pacemakers. The Times’ reporting showed the company had identified battery performance problems through internal testing and regulatory interactions years before expanding its public warnings.
Last week, Boston Scientific posted advisories on its own website describing the issue in technical terms and describing software updates intended to mitigate risk. The advisory carried an ominous headline – “Urgent Medical Device Correction.” The company, while continuing to advise against routine preemptive removal, said some devices had a roughly 7.6 percent probability of needing early replacement.
The company’s public disclosures — issued as a series of technical advisories rather than traditional recall announcements — described the issue as a manageable battery condition, even as the scope of affected devices continued to expand.
Boston Scientific didn’t respond to our questions. The company’s chief medical officer, Dr. Kenneth Stein, told the Times that his company, which is the world’s third-leading manufacturer of pacemakers by sales revenue, has struggled to get to the bottom of the issue. “It’s turned out to be a very complicated problem, one that’s required a lot of really diligent investigation.”
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. His next book, Summer of ’71: Five Months That Changed America, about the fateful year before Watergate, will be out in June. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.
