Experts call for data transparency with recalled medical devices

Over the last few years, some patients have been receiving implantable cardioverter-defibrillators (ICDs) that are subject to Class I recalls. These devices have continued to be implanted, breaking with precedent, largely based on assurances and safety analyses from the device manufacturer, according to a perspective article published in the New England Journal of Medicine.

“The decision to continue to market and implant the relevant devices relied primarily on the manufacturer’s analysis of its own data, which aren’t widely available. Patients and the medical community are therefore confronted with an important clinical decision, without independent science to guide them,” wrote Daniel B. Kramer, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and Robert G. Hauser, of the Minneapolis Heart Institute Foundation.

The concerns relate to several models of Medtronic’s Cobalt and Crome ICDs, which were identified in June 2022 as having a problem with delivering a full-energy shock during a ventricular arrythmia, and in May 2023 as having a malfunction with the “glassed feedthrough” that could potentially deliver a reduced energy shock during high-voltage therapy. The US Food and Drug Administration (FDA) categorized both manufacturer recalls as being Class I, the highest risk level.

In the case of the June 2022 advisory, the manufacturer released a software update that resolved the problem. For the issue that led to the May 2023 advisory, the manufacturer recommended modifying the shock polarity of the device, but Kramer and Hauser noted there is currently no software update, hardware modification or manufacturing fix for the issue. Additionally, the manufacturer determined based on their analysis that the June 2022 issue impacted 95 devices (0.07%) and carried a 0.002% risk of death compared with a mortality risk of 0.032% to 0.043% for prophylactic reimplantation. Similarly, the May 2023 issue impacted 32 devices and the likelihood of the error was estimated to be 0.002% at 5 years if the shock polarity was corrected.

Kramer and Hauser argued that there should be a multi-stakeholder study involving FDA, cardiology professional societies and the manufacturer to “better define the risk of shock failures and associated patient harms,” which would not be adequately captured by existing national registries.

“We propose that the manufacturer consider sharing the complete data sets from its product-tracking and remote-monitoring systems with an academic coordinating center, which could evaluate the data using additional prespecified analytic techniques, independently support the published estimates of malfunction rates, determine the relevance of shock polarity to patient outcomes, and establish whether these models meet a sufficiently high standard for performance,” the authors wrote.

Performance updates for recalled devices should also be published, the authors argued, and include adverse event summaries that are relevant to the recalls.

“Manufacturers necessarily have the most up-to-date and complete data related to their own implantable devices and can play an important role in educating the clinical community about ongoing device performance while collaborating with independent investigators who could confirm their findings,” Kramer and Hauser wrote. “Patients and clinicians have a right to transparency when it comes to device performance.”

The authors urged clinicians to “carefully consider” using recalled devices since there are other manufacturers producing ICDs with identical implantation procedures and similar device functions and features.

“Even in relatively low-risk settings, with other options available, the decision to continue using these devices rests on key assumptions about the importance of this mechanism of device failure for outcomes,” Kramer and Hauser wrote. “If physicians continue to implant recalled devices, we recommend that they adhere to the principles of informed consent and talk with patients about the Class I recalls and why a particular device is preferred over alternatives.”

NEJM Perspective

Experts call for data transparency with recalled medical devices

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