I. The Classification

The Medical Device Amendments of 1976 gave the Food and Drug Administration a risk-based classification system, codified at Section 513 of the Federal Food, Drug, and Cosmetic Act. Every medical device is assigned to one of three regulatory classes, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.¹ Class I devices, low to moderate risk, are subject to general controls. Class II devices, moderate to high risk, are subject to general controls and special controls. Class III devices, high risk, are subject to general controls and premarket approval.¹

A device cannot be Class I if it is purported or represented to be for a use in supporting or sustaining human life, or for a use of substantial importance in preventing impairment of human health, unless it presents no unreasonable risk.² And under Section 513(f)(1), a device first marketed after May 28, 1976, the Amendments’ effective date, is automatically Class III, unless it is found substantially equivalent to a legally marketed predicate.³ The device this investigation concerns supports and sustains human life, presents an unreasonable risk of illness or injury when it malfunctions, was first marketed well after 1976, and has no predicate. The classification follows from the agency’s own rules.

II. The Approved Unit

On October 15, 2004, the Food and Drug Administration approved Premarket Approval Application P030011 for the Syncardia temporary CardioWest Total Artificial Heart.⁴ The application had been filed on April 11, 2003, and amended on June 12, 16, 17, 19, and 20, October 14, and November 20, 2003, and February 10, March 2, August 13, and September 22, 2004.⁴ Eighteen months of review, twelve amendments, for a device indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure, for use inside the hospital only.⁴

The approval restricted the sale, distribution, and use of the device to prescription use, and further restricted it to practitioners whose training met requirements specified in the labeling.⁴ To earn the approval, the sponsor had to provide valid scientific evidence demonstrating reasonable assurance of the device’s safety and effectiveness for its intended use. The agency completed its review, found the evidence sufficient, and issued the order. One artificial heart, one application, eighteen months, twelve amendments, and a training mandate for every practitioner who touches it.

III. The Unapproved Unit

The unapproved unit performs the identical function. According to the American Heart Association, the average human heart beats approximately 100,000 times per day and pumps approximately 2,000 gallons of blood per day.⁵ The Association’s classroom materials put the annual throughput at roughly 730,000 gallons per year.⁵ In a seventy-year lifetime, the average human heart beats more than 2.5 billion times.⁵

The unit’s timing is governed by the sinoatrial node, the heart’s natural pacemaker, a cluster of cells in the right atrium that generates the electrical impulse initiating each heartbeat without any external stimulus.⁶ The approved device requires a pneumatic driver to operate. The unapproved device generates its own electricity, carries its own power supply, and has never once required an external driver, a battery replacement, or a firmware update.

A careful reader will note that the Federal Food, Drug, and Cosmetic Act was written with manufactured devices in mind. This investigation notes it too, and proceeds anyway, on the authority of the agency’s own classification logic. When the agency defines a Class III device as one that supports and sustains human life and presents an unreasonable risk of injury when it malfunctions, this publication takes the agency at its word. The words “supports and sustains human life” are doing the work. The classification is doing the rest.

IV. The Installed Base

The Census Bureau counted 340.1 million residents of the United States on July 1, 2024.⁷ The device is standard equipment, installed in approximately one unit per resident. The installed base of the unapproved device is therefore on the order of 340 million units, circulating continuously, every day, in every state.

For comparison, consider the approved comparator. In its entire commercial history, the Syncardia total artificial heart has been implanted in just over one thousand patients, accounting for more than two thousand diaphragms, two per device.⁸ The ratio of unapproved units in circulation to approved-class implants ever performed is approximately 340,000 to 1.¹³ Of the 340 million, not one has a premarket approval, a 510(k) clearance, a De Novo grant, or a humanitarian device exemption. The paperwork file is empty. The devices are everywhere.

V. The Adverse-Event Record

The National Vital Statistics System reports that diseases of the heart caused 702,880 deaths in the United States in 2022, the leading cause of death, accounting for 21.4 percent of all deaths, one in every five.⁹ Cardiovascular disease kills one American every 33 seconds.⁹ Heart disease and stroke cost the health system and the economy approximately $252.2 billion in 2019 and 2020 in health care services, medicines, and lost productivity due to death.¹²

Under the Medical Device Reporting regulation at 21 CFR Part 803, manufacturers are required to report to the Food and Drug Administration when they learn that any of their devices may have caused or contributed to a death or serious injury, and when a device has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if it recurred.¹⁰ Reportable events must generally be submitted within 30 calendar days after the day the manufacturer becomes aware of the event.¹⁰ “Becomes aware” is defined to include awareness by any employee of the manufacturer.¹⁰

Every heart-disease death in America is recorded on a death certificate that names the cause. The reporting clock has therefore been running, continuously, since the Medical Device Amendments of 1976, a period of fifty years. In that time, no medical device report has ever been filed for a human heart. No Form 3500A, no baseline report, no malfunction report, no 5-day report. The agency’s adverse-event database holds nothing under the operator’s name, because the operator has never registered and therefore does not exist in the agency’s records.

VI. The Replacement Market

The only replacement channel for a failed unit is transplantation. In 2022, 4,111 heart transplants were performed in the United States, a record, according to the Organ Procurement and Transplantation Network.¹¹ The American Heart Association’s 2026 statistics put the most recent annual figure at approximately 4,500 transplantations, with more than 3,700 people remaining on the waiting list.¹¹ Against an installed base of 340 million units, the annual replacement rate rounds to zero.

Each replacement unit is itself an unapproved device, recovered from a donor and installed without premarket review of any kind. And the approved device’s indication closes the circle: the Syncardia artificial heart, reviewed for eighteen months and granted premarket approval, is indicated as a bridge to transplant, which is to say, a bridge to receiving another unapproved unit. The regulatory system approves the bridge. It has never approved the destination.

VII. The Labeling Gap

General controls include labeling. Devices must bear labeling with adequate directions for use, and the Syncardia approval letter restricted that device to prescription use and to practitioners whose training the labeling specified.⁴ The approved device may not be operated by an untrained user. Its labeling says so.

The unapproved device ships with no labeling at all. No directions for use, no patient information leaflet, no contraindications, no training requirement for the operator. The device is installed before birth and operated continuously for decades, at 100,000 cycles per day, by a user who has received no instruction, holds no certification, and cannot name the device’s manufacturer. The operator cannot even read the labeling, because there is none.

VIII. The Enforcement Impossibility

Section 331 of the Act prohibits the introduction of adulterated or misbranded devices into interstate commerce. The device enters no commerce. Its distribution channel is birth, which predates the Medical Device Amendments by the entirety of human history and crosses no state line in a shipping carton. Section 518 of the Act, which the agency’s own Federal Register notices list among its general controls, authorizes orders for the repair, replacement, or refund of a defective device.¹⁴ The authority has never been exercised against a single human heart. No field correction has been ordered. No safety communication has been issued. No recall, voluntary or mandatory, has ever named the operator.

The agency could demand the premarket approval application that Section 515 requires. The application would have to list, as the device, approximately 340 million units; as the intended use, supporting and sustaining human life; as the clinical evidence, fifty years of continuous operation; and as the applicant, no one. The Center for Devices and Radiological Health has no form for no one.

The classification system has stood for fifty years. In that time the operator has distributed approximately 340 million unapproved Class III devices, filed no premarket approval application, submitted no medical device report for 702,880 annual failures, labeled nothing, trained no operator, and answered no recall. The approved device took eighteen months and twelve amendments to clear. The unapproved device clears 100,000 cycles a day, generates its own electricity, and operates on.

Ergo.