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# FDA Faulted for Lax Device Issue Follow-up
- URL: https://www.fdaweb.com/fda-faulted-for-lax-device-issue-follow-up/
- Published: 2021-08-05T12:00:00.000Z
- Updated: 2026-09-14T17:09:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149871

In a detailed report, the investigative newsroom *Pro Publica* says FDA relies too much on medical device manufacturers to correct problems with their products and takes too little action to ensure compliance. The [report](https://www.propublica.org/article/heartware-patients-implanted-fda?ref=fdaweb.com) focuses primarily on the HeartWare ventricular assist device (HVAD) used as a heart pump while a patient awaits a heart transplant. HeartWare was acquired by Medtronic in 2016 and the device was pulled from the market in 2020.

“As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up,” *Pro Publica* says, “FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.” It says that by the end of 2020, the agency has received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.

“The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses,” the report says. “For decades, FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies, or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.”

The report says that when FDA found repeated manufacturing issues with the HVAD for years, it didn’t penalize the company, even as the company conducted 15 Class 1 recalls from 2014 on. And, it says, the processes to inform the public through formal FDA notices and messages to healthcare providers repeatedly failed and left patients in the dark about known problems with the HVAD.

In response to *ProPublica*’s report, FDA said it had been closely monitoring issues with the HVAD and, after Medtronic acquired the company, met with Medtronic more than 100 times to ensure problems were being fixed and to review safety concerns. FDA also said it initiated a formal review of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”

“Our decisions we made along the way have always been patient-focused,” said CDRH director of product evaluation and quality **William Maisel**. He reported that more than 80% of companies fix their problems by the time FDA reinspects.

Medtronic declined to make top officials available to *Pro Publica* and in an e-mail said, “There is nothing more important to Medtronic than the safety and well-being of patients. Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the Warning Letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”