Partner at AKD Lawyers
Practice Areas: Personal Injury
A medical device should help you, not leave you dealing with new health problems. But a faulty implant, pacemaker, or surgical tool can cause injuries and may mean more treatment or another operation.
The FDA recalls devices when a safety problem arises or the product doesn’t meet requirements. If you use a recalled device, talk to your doctor about what to do next. Do not stop treatment or remove an implant on your own.
If a device has injured you, you may also have legal options. A New Orleans defective medical device lawyer can help you understand your rights under Louisiana law.
How Does the FDA Recall Process Work?
A recall starts when a company finds a problem with a medical device. The company may need to fix the device, replace it, or stop selling it.
The FDA checks how recalls are handled. Under 21 CFR Part 7, companies can start recalls themselves. In some cases, the FDA can also require a recall.
Here is what happens:
- A problem is found. The company learns that a device may be unsafe.
- The company takes action. It decides whether to fix, replace, or remove the device.
- People are told. Hospitals, doctors, and patients may receive a notice with instructions.
- The FDA checks the risk. It may place the recall into one of three classes.
- The recall is followed up. The FDA checks whether the company is taking the needed steps.
Patients and doctors can also report medical device problems to the FDA. These reports help the FDA spot possible safety issues. A report alone does not prove that a device caused an injury.
What Are the Three Classes of Medical Device Recalls?
The FDA puts recalls into three classes based on the possible harm to patients.
| Recall class |
What it means |
| Class I | The device could cause serious harm or death. |
| Class II | The device could cause temporary harm or, in rare cases, serious harm. |
| Class III | The device is unlikely to cause harm. |
The recall notice explains what users should do. Some people may need extra checkups, while others may need a different device. If you have an affected device, ask your doctor what the recall means for you.
What Do Medical Device Recall Services Do?
When a company recalls a device, it must find affected products and tell people what to do. Some companies handle this work themselves. Others hire outside services.
The work may include:
- Finding affected products: Checking product names and numbers.
- Sending notices: Telling hospitals, doctors, and other users about the recall.
- Fixing devices: Arranging repairs or updates.
- Taking products back: Organizing returns, replacements, or safe disposal.
- Keeping records: Tracking which products have been found or fixed.
These services help manage the recall. They don’t decide whether a patient can seek compensation for an injury.
Which Medical Devices Can Be Recalled?
Recalls can affect many types of devices, including:
- Hip implants: Some may wear down, loosen, or break.
- Pacemakers: Battery or software problems may affect how they work.
- Surgical mesh: Some products have been recalled over safety concerns.
- Blood glucose monitors: Wrong readings can lead to treatment mistakes.
- Breast implants: Certain models have been recalled over health risks.
- Surgical electrodes: Some have been recalled after reports of burns during surgery.
A recall does not mean every device of that type is unsafe. Check the product name and model number to see if yours is affected.
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Megadyne Electrode Recalls and Burn Injuries
Certain Megadyne MEGA SOFT and MEGA 2000 patient return electrodes have been recalled after reports of burns during surgery. These devices help carry electrical current back from the patient’s body during an operation. Some patients suffered serious burns that needed medical care or another operation.
The instructions depend on the model:
- MEGA SOFT Pediatric (0840): The product was recalled, and users were asked to stop using it.
- Certain MEGA SOFT Universal and Universal Plus models: Updated instructions limited use to patients aged 12 and older.
- Certain MEGA 2000 and MEGA SOFT models: Other safety changes or instructions applied.
If you suffered a burn during surgery, ask the hospital for your surgical records. These may help identify which device was used. The recall alone does not prove that the electrode caused your injury, but the records may help explain what happened.
What Should You Do If Your Device Is Recalled?
If you find out that your device has been recalled, start with these steps:
- Call your doctor. Ask whether you need a checkup, more care, or a replacement device.
- Read the recall notice. Check the product name, model number, and instructions.
- Follow medical advice. Do not stop treatment or remove an implant without speaking to your doctor.
- Keep your records. Save the recall notice, medical bills, and treatment records.
- Report problems. You can report device issues through the FDA’s MedWatch program.
If you were hurt, write down when your symptoms began and what treatment you needed. Keep any letters or messages about the device, too.
Can You Sue Over a Defective Medical Device in Louisiana?
You may be able to bring a claim if a faulty device caused your injury. The Louisiana Products Liability Act governs claims against manufacturers.
A claim may involve:
- A manufacturing defect: The device was made incorrectly.
- A design defect: The device was designed in a way that made it unreasonably dangerous.
- Missing safety warnings: The company failed to give the warnings or instructions required by law.
- A broken promise: The product did not meet a promise covered by the law.
You must show that the device caused your injury and meet the other legal requirements. A recall may support your claim, but it does not prove the company is at fault on its own.
If your claim succeeds, you may recover money for medical bills, lost wages, pain, and future care. Learn more about your legal options after a medical device failure.
Frequently Asked Questions
Can I sue a manufacturer if its device was recalled?
Possibly. You must show that the device caused your injury and that your claim meets Louisiana law.
Do I need to keep the recalled device to make a claim?
Not always. Medical records, product details, and surgery reports may help show which device was used.
Can I bring a claim if the device was never recalled?
Yes, you don’t always need a recall to bring a claim. The evidence and legal rules will determine whether you have a case.
Can a lawyer help with burns linked to a Megadyne electrode?
Yes. A lawyer can review your medical records, find out which electrode was used, and assess whether you may have a claim.
Who pays for treatment after a defective device causes an injury?
Health insurance or other coverage may pay some costs. If you have a valid claim, you may also seek money for medical bills and other losses.
Speak With a Louisiana Defective Medical Device Lawyer
If a medical device has hurt you or someone in your family, you may be worried about medical costs and what to do next. You do not have to work through the legal questions alone.
Alvendia, Kelly & Demarest Law Firm helps injured people in Louisiana understand their options. Request a free consultation to discuss your situation.
Reviewed by Roderick “Rico” Alvendia, Partner at Alvendia, Kelly & Demarest Law Firm.
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In 2003, after being dissatisfied with the quality of legal care for victims of car accidents, Roderick ‘Rico’ Alvendia sought to establish a new firm focused on providing high-quality legal services to aid injured victims and their families. J. Bart Kelly, sharing Rico’s passion for upholding justice, joined the firm later that year, and established a partnership.
