On this page
Houston Heart Devices: Key Facts When Heart Devices Fail Claims Against High-Risk Device Makers Contact Our Houston Office Frequently Asked QuestionsTHE LAW GIANT product liability lawyers:
We Fight for Your Rights
Many heart devices go through the FDA’s strictest review, which limits some claims against their makers. Claims based on a maker breaking FDA rules, including the duty to report injuries, can still go forward.
Call The Law Giant at 956-982-1800 or contact us online for a free consultation. You pay nothing unless we win.
Houston Heart Devices: Key Facts
- The world’s first total artificial heart was implanted in Houston on April 4, 1969. The surgery took place at the Texas Heart Institute.
- The Texas Heart Institute implanted its 1,000th LVAD heart pump in 2014. Its history also notes a first-in-human artificial heart implant in 2024.
- The Texas Medical Center reports more than 13,600 heart surgeries a year. The figure is on its facts page, alongside 180,000 surgeries of all kinds.
- FDA reported 129 serious injuries, including 49 deaths, tied to one heart pump problem. The 2024 Class I recall warned the Impella pump could perforate the heart wall.
When Heart Devices Fail
Heart devices keep people alive, so a defect can be catastrophic. Claims often involve:
- Heart pumps and LVADs that clot, stop or damage the heart.
- Pacemaker and defibrillator leads that fracture or deliver shocks at the wrong time.
- Batteries that drain early, forcing replacement surgery.
- Instructions for use that fail to warn doctors about a known risk.
A recall, an FDA safety communication and the maker’s injury reports are often the starting points for proof.
Claims Against High-Risk Device Makers
Many heart devices are Class III devices approved through premarket review. In Riegel v. Medtronic (2008), the Supreme Court held that state claims adding to federal requirements for those devices are preempted. Claims that mirror federal requirements survive.
The Duty to Report Injuries
Device makers must report to FDA when they learn their device may have caused or contributed to a death or serious injury, under the agency’s mandatory reporting rules. Hospitals must report suspected device-related deaths.
Keep reading
In Hughes v. Boston Scientific (2011), the federal appeals court covering Texas held that a claim based on a maker’s failure to report serious injuries to FDA was not preempted.
Getting the Records
We request device data, explant reports and the hospital’s records, and we search FDA’s adverse event database for similar reports. FDA cautions that those reports cannot show failure rates on their own.
Contact Our Houston Office
Our Houston office is at 2450 Fondren Rd. If your device was removed, ask the hospital in writing to preserve it. See our Houston product liability, dangerous drug and wrongful death pages. For statewide rules, see our Texas defective medical device page.
Call 956-982-1800. You pay nothing unless we win.
Common Questions
Houston Medical Device FAQs
My defibrillator shocked me without reason. Do I have a claim?
Possibly. Device data can show whether a lead or software defect caused the shock. Keep records of every event and ask your cardiologist for the device report.
Can I sue the maker of a heart device the FDA approved?
Sometimes. Claims that the maker violated FDA requirements, such as manufacturing or reporting rules, can survive even for approved devices.
My LVAD was replaced. What happens to the old one?
Ask the hospital in writing to keep it. The explanted device can be key evidence, and makers often ask to take it back.
How do I report a device problem to the FDA?
Patients can file a report through FDA’s MedWatch program online. Your report can help others and creates a record.
How long do I have after a heart device injury?
Generally two years from the injury, and product claims must also be filed within 15 years of the device’s sale.
Giant Wins for All Injuries
Our personal injury lawyers handle a wide range of accidents and serious injuries across Texas.
The Law Giant Stands With You
More About The Law Giant →
4.9 