FDA High-Risk Alert Issued for Flexible Cryoprobes After Device Ruptures Cause Hearing Loss and Injuries

Patients and medical staff injured by rupturing cryotherapy probes may have legal options under product liability laws.

The U.S. Food and Drug Administration recently issued a high-risk safety alert involving Flexible Cryoprobes manufactured by Erbe USA, a medical device company based in Marietta, Georgia. These devices are widely used in interventional radiology procedures where extreme cold is applied to destroy or remove abnormal tissue.

What Parker Waichman LLP Found

• The FDA issued a high-risk safety alert involving Flexible Cryoprobes used in medical procedures.
• A manufacturing defect involving insufficient adhesive may cause device rupture during activation.
• More than 90,000 units were distributed before the defect was identified.
• At least five serious injuries have been reported, including hearing damage and burns.
• Individuals injured during procedures involving these devices may have grounds to file a product liability lawsuit.

Cryoprobes are often used during delicate procedures to remove tumors, extract foreign bodies, clear mucus plugs, remove necrotic tissue, or obtain biopsies. Because these procedures frequently occur in sensitive areas of the body, medical teams depend on these instruments to operate safely and predictably.

Federal regulators issued the alert after reports that certain cryoprobes can rupture or burst when activated. According to information released to healthcare providers, the failures may be linked to a manufacturing defect involving insufficient adhesive during assembly. This flaw may lead to excessive internal pressure when the probe is activated.

When a rupture occurs, it can create a sudden explosive sound and release extremely cold gas. The consequences can be serious for patients, surgeons, nurses, and other medical staff standing nearby. Federal officials confirmed that at least five serious injuries have already been reported in connection with this issue.

The FDA has categorized this situation as a high-risk medical device safety concern, meaning the malfunction may cause significant harm if the device is used during a medical procedure.

How Flexible Cryoprobes Are Used During Medical Procedures

Flexible Cryoprobes are specialized medical tools used in interventional radiology and endoscopic procedures. The device works by delivering extremely cold temperatures to targeted tissue, which freezes and destroys abnormal cells. This process, known as cryotherapy or cryoablation, is widely used in modern medicine.

Doctors rely on cryoprobes in procedures involving:

• Removal of tumors
• Tissue biopsies
• Clearing blood clots
• Removing mucus plugs in the airway
• Extracting foreign objects from the body
• Removing necrotic or damaged tissue

During these procedures, the probe is activated to rapidly cool the targeted area. The freezing process causes tissue destruction or allows surgeons to remove tissue more easily.

Because cryotherapy involves extreme cold and pressurized gas systems, the device must be manufactured with precise materials and strict safety standards. A structural defect can cause a sudden release of pressure, which may lead to equipment rupture.

When a medical instrument bursts during use, the risks extend beyond the intended treatment area. The event can expose everyone in the operating room to loud acoustic shock, cold burns, and flying fragments.

Manufacturing Defect Linked to Cryoprobe Ruptures

According to information released by the manufacturer and federal regulators, the device failures may stem from a manufacturing defect involving insufficient adhesive applied during production.

Adhesive components play a critical role in maintaining the structural integrity of pressurized medical devices. If the bonding process is incomplete or inconsistent, pressure can build inside the instrument during activation.

The FDA reports that the defect can cause excessive input pressure, which may lead to a rupture of the cryoprobe.

A rupture may result in several dangerous outcomes:

• A sudden explosive sound
• Release of pressurized gas
• Exposure to extremely cold temperatures
• Device fragments or debris
• Immediate interruption of a medical procedure

These events can occur unexpectedly when the device is activated during treatment.

The manufacturer issued an urgent medical device recall notice to customers on February 12, advising hospitals and healthcare providers to discontinue use of products from certain affected lot numbers.

The recall affects more than 90,000 units of the cryoprobes distributed to medical facilities.

Injuries Reported From Cryoprobe Ruptures

As of February 24, the manufacturer reported 43 complaints related to the defect, all categorized as adverse events.

Federal officials confirmed five serious injuries associated with the malfunction.

Reported injuries include:

• Tinnitus (ringing in the ears)
• Temporary hearing loss
• Persistent hearing loss
• Minor burns
• Hand injuries such as hyperextended fingers
• Hand pain caused by the rupture event

The loud acoustic shock created by the rupture can be powerful enough to damage hearing. This risk affects not only patients undergoing treatment but also surgeons, nurses, technicians, and other individuals present in the room.

Even when hearing damage is temporary, the experience can be frightening and disruptive. In more serious cases, patients or healthcare professionals may suffer permanent auditory damage.

Burn injuries can also occur when extremely cold gas escapes the ruptured device.

Why Device Failures During Medical Procedures Are So Dangerous

Medical procedures rely on precise timing, careful coordination, and equipment that functions reliably.

When a surgical device suddenly fails, several dangerous situations may occur simultaneously.

First, the procedure itself may be interrupted. If a tumor removal, biopsy, or airway procedure stops unexpectedly, the patient may require additional surgery or medical intervention.

Second, the physical rupture of the device can injure anyone nearby. Loud noise, sudden pressure release, and cold gas exposure all present hazards in an operating environment.

Third, the emotional impact of a device malfunction during a procedure can be severe. Patients trust that medical devices have been properly designed and tested. When equipment fails during treatment, that trust can be shattered.

Manufacturers of medical devices are responsible for ensuring that products meet strict safety standards before being released into hospitals and surgical centers.

If design flaws, manufacturing defects, or quality control failures allow dangerous devices to enter the marketplace, injured individuals may pursue legal claims.

Legal Rights After an Injury Caused by a Defective Medical Device

Patients and medical staff injured by defective medical devices may have the right to pursue compensation through a product liability lawsuit.

Medical device litigation may involve several legal claims, including:

• Defective manufacturing
• Defective design
• Failure to warn about risks
• Negligent quality control
• Failure to conduct adequate testing

Manufacturers have a duty to identify and correct potential safety hazards before distributing devices used during medical treatment.

When companies fail to meet those obligations, injured individuals may seek compensation for:

• Medical expenses
• Hearing treatment or rehabilitation
• Lost wages
• Pain and suffering
• Long-term disability

Investigating these cases often requires reviewing medical records, device lot numbers, manufacturing data, and recall documentation.

Lawsuit FAQs

Who may file a lawsuit related to the cryoprobe recall?
Patients who suffered injuries during procedures involving Flexible Cryoprobes may be eligible to pursue a claim. In addition, healthcare professionals injured by the device rupture may also have legal rights depending on the circumstances.

What types of injuries may qualify for compensation?
Potential claims may involve hearing damage, tinnitus, burns, hand injuries, or complications resulting from interrupted medical procedures. Any injury that can be linked to the defective device may be considered.

How do I know if the device used during my procedure was recalled?
Medical records, hospital equipment logs, and product lot numbers can help determine whether the device involved in the procedure came from an affected batch. Legal teams often work with medical facilities to obtain this information.

Is hearing loss from a medical device rupture permanent?
Some cases involve temporary hearing damage, while others may result in lasting impairment. Audiological testing and medical evaluation can determine the extent of injury.

What compensation may be available?
Compensation may include reimbursement for medical bills, treatment costs, lost wages, pain and suffering, and long-term care related to hearing loss or other injuries.

How long do I have to file a claim?
Each state has a statute of limitations that limits how long a person has to bring a lawsuit. The timeline can vary depending on where the injury occurred and when the injury was discovered.

What evidence is needed for a case?
Medical documentation, device recall notices, incident reports, and testimony from medical professionals may help establish the connection between the device defect and the injury.

If you or a loved one were injured during a medical procedure involving a Flexible Cryoprobe, you may have the right to pursue a lawsuit.

Contact Parker Waichman LLP For A Free Case Review

Parker Waichman LLP represents individuals harmed by defective medical devices and dangerous products. The firm is investigating injuries linked to rupturing cryoprobes and offers free consultations to affected individuals.

Call 1-800-YOUR-LAWYER (1-800-968-7529) to discuss your situation and learn about your legal options. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.