FDA warns doctors to stop using heart pump tied to deaths

U.S. health regulators warned surgeons Thursday to stop implanting a heart pump made by Medtronic due to power failures recently tied to cases of stroke and more than a dozen deaths.

Associated Press

Jun 3, 2021, 6:57 PM

Updated 1,050 days ago

Share:

FDA warns doctors to stop using heart pump tied to deaths
U.S. health regulators warned surgeons Thursday to stop implanting a heart pump made by Medtronic due to power failures recently tied to cases of stroke and more than a dozen deaths.
Medtronic said earlier in the day it would stop selling its Heartware assist device, which is intended to boost blood circulation in patients with heart failure.
Recent company data showed the device can unexpectedly stop working and sometimes fail to restart, the Food and Drug Administration said. The company said it hasn’t been able to pinpoint the root cause in every case.
Surgeons can use implants from other manufacturers, the FDA said in a memo to physicians.
About 4,000 people worldwide currently have the Medtronic device, roughly half of them in the U.S. For those patients, the agency said U.S. doctors should contact the company for the latest guidance on managing the device, which includes managing blood pressure.
The FDA said Medtronic halted sales after reviewing 100 reports of power failures with the device, which led to 14 patient deaths and 13 patients having it removed. The company previously issued recalls on some Heartware devices and components used when implanting it. In December, the company warned about power failures or delayed restarts with three lots.
The company said patients should not automatically have the device removed. Taking out recalled heart implants has to be carefully weighed against the potential risks of surgery. Medtronic said in a statement physicians should decide “on a case-by-case basis, considering the patients clinical condition and surgical risks.” The company said it is preparing a guide for managing patients “who may require support for many years.”
The Heartware device was used for heart failure patients awaiting transplant or as a permanent implant for those who weren’t healthy enough for that procedure. The device helps strengthen one of the heart’s lower chambers needed for adequate blood circulation.
Medtronic is one of the world’s largest medical device and equipment makers, selling thousands of implants used to treat heart, neurological and joint conditions.


More from News 12
2:05
New retail theft prevention plan in state budget includes harsher charges, more patrols

New retail theft prevention plan in state budget includes harsher charges, more patrols

2:05
Mostly cloudy skies and cool conditions on Long Island

Mostly cloudy skies and cool conditions on Long Island

2:00
Alleged Gilgo Beach serial killer’s defense attorney demands information on other ‘top suspect’

Alleged Gilgo Beach serial killer’s defense attorney demands information on other ‘top suspect’

0:22
Police probe multivehicle crash on Southern State Parkway

Police probe multivehicle crash on Southern State Parkway

0:23
Police: 1 man faces charges for selling cannabis, illegal vape products at Huntington Station shop

Police: 1 man faces charges for selling cannabis, illegal vape products at Huntington Station shop

0:26
Police: Wyandanch man arrested for recklessly driving dirt bike

Police: Wyandanch man arrested for recklessly driving dirt bike

0:14
Police: Suspect wanted for stealing over $3,000 worth of sunglasses from Lake Grove store

Police: Suspect wanted for stealing over $3,000 worth of sunglasses from Lake Grove store

Is your mom awesome? Long Island tell us why your Mom Rocks!

Is your mom awesome? Long Island tell us why your Mom Rocks!

Show off your team spirit! Share your photos with News 12

Show off your team spirit! Share your photos with News 12

1:55
The Real Deal: How tipping trends have changed in the tri-state area

The Real Deal: How tipping trends have changed in the tri-state area

1:30
Police: Car drives into Plainview dance studio; 3 suffer minor injuries

Police: Car drives into Plainview dance studio; 3 suffer minor injuries

1:50
Concern growing over homeless shelter near West Babylon day care

Concern growing over homeless shelter near West Babylon day care

2:00
John Theissen Children's Foundation opens Family Fun Center in Wantagh

John Theissen Children's Foundation opens Family Fun Center in Wantagh

0:54
Guide: How to host Passover on a budget

Guide: How to host Passover on a budget

0:13
Officials: West Babylon home destroyed by fire

Officials: West Babylon home destroyed by fire

0:47
Cafe 217 provides students with autism chance for work experience at East Rockaway HS

Cafe 217 provides students with autism chance for work experience at East Rockaway HS

0:42
Community raises $12,000 for workers of Merrick bar closed due to fire

Community raises $12,000 for workers of Merrick bar closed due to fire

0:23
Police: Hempstead man stole parking meters near Jericho Turnpike and Roslyn Road

Police: Hempstead man stole parking meters near Jericho Turnpike and Roslyn Road

1:55
8-year-old from Valley Stream becomes first in NY to undergo gene therapy for rare disease

8-year-old from Valley Stream becomes first in NY to undergo gene therapy for rare disease

2:27
2016 whistleblower tip warned of barrels buried at old Grumman property in Bethpage

2016 whistleblower tip warned of barrels buried at old Grumman property in Bethpage