Industryweek 12036 Hvad 1

Medtronic Heart Pump Recall Deemed Life-Threatening by FDA

Sept. 30, 2016
The device that was recalled, called the HVAD System, takes over for a failing heart. One patient may have died because of a flaw where moisture can penetrate the mechanical pump through loose power or data connectors.  

Flaws with a heart device that Medtronic Plc bought last month as part of a $1 billion deal have been deemed potentially life-threatening by U.S. regulators.

The device, called the HVAD System, takes over for a failing heart. One patient may have died because of a flaw where moisture can penetrate the mechanical pump through loose power or data connectors, said Chris Garland, a spokesman for the company. Medtronic acquired the device with its purchase last month of HeartWare International.

Doctors and patients were first notified about the issue in May and June, with instructions to closely monitor the HVAD System for loose connections, the company said in a statement Friday. The U.S. Food and Drug Administration has since classified the issue a Class 1 recall, meaning the problem is potentially life-threatening. Recall designations are used to classify an issue’s severity, and doesn’t mean that the devices necessarily need to be removed from patients and replaced.

Almost all 8,799 patients who could be affected have been notified, and 308 controllers have been replaced, the company said.

Last month, the company recalled the pump kits that were in hospital inventories because they were vulnerable to electrical faults and connection failures from exposure to moisture. The company has recovered 323 of those 350 at-risk kits.

By Michelle Fay Cortez

Popular Sponsored Recommendations

Shop Floor Optimization Solves Manufacturers’ Labor Challenges

Dec. 27, 2023
Read this FAQ to learn how mid-market manufacturers can use technology to optimize their shop floors and make better use of their available labor forces.

Sprint Implementation for Digital Transformation

Feb. 1, 2024
Discover a revolutionary approach to digital transformation. Uncover the flaws in current methods that cause 70% project failure rate. Learn how sprint implementation can maximize...

Service Lifecycle Management – Challenges and Opportunities

Feb. 18, 2024
Gain insights into the next wave of aftermarket optimization with Harvard Business Review’s whitepaper, in association with Tavant. Get an in-depth look at AI-powered Service ...

Top 3 Ways AI is Transforming Manufacturing Operations

Feb. 17, 2024
Unlock the power of Industry 4.0 with AI and IoT. Explore how real-time data and automation are reshaping manufacturing, driving efficiency and quality to new heights. Dive into...

Voice your opinion!

To join the conversation, and become an exclusive member of IndustryWeek, create an account today!