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Medtronic Voluntarily Recalls Catheters and Other Medical Devices Due to PTFE Issues


New FDA Recall: Catheters and Other Medical Devices

recalls-catheters-and-other-medical-devices-due-to-ptfe-issues

In the medical device field, design flaws can be serious and even deadly. On October 14, 2016, manufacturer Medtronic decided to be proactive and responsible by announcing a voluntary recall on certain catheters, guidewires, embolization devices and retrieval devices. Although no patient injuries had been reported yet in correlation with the use of these products, the company wanted to alert patients and physicians of the possibility of the coating coming off and causing adverse medical events.

The Issue

The devices affected by this recall are coated with polytetrafluoroethylene (PTFE). It is believed that the PTFE coating could separate from the wires or other parts of the device. If this were to occur, the particles could travel into the bloodstream. Based on the number of particles and their size, they could trigger an adverse health event in the patient, such as an embolism, stroke or other blood flow-related medical condition.

Affected Products

The following products – all which were created and sold by Medtronic’s Neurovascular business in the Restorative Therapies Group – have been affected by this recall:

Product NameNumber of Affected Lots
Alligator™ retrieval device171
X-Celerator™ hydrophilic guidewires210
Pipeline™ embolization device1,742
UltraFlow™ HPC flow directed micro catheters/ Marathon™ flow directed micro catheters1,790

Communication

On October 5, 2016, Medtronic – one of the world’s largest medical device companies – initiated communication with patients through letters. Patients were advised of the recall and possible situation. The company asked that all affected inventory that had not been used be returned. Regulatory agencies such as the Food and Drug Administration (FDA) have been notified of the recall.

The affected units – which total 84,278 – has been distributed worldwide and manufactured between July 2014 and September 2016.

Uses

The Alligator™ retrieval device is used for foreign body retrieval in the peripheral and neuro-vasculature. The X-Celerator™ hydrophilic guidewire is used to assist physicians with placing catheters in the visceral, peripheral and cerebral vasculature during therapeutic and diagnostic procedures.

The Alligator™ retrieval device

The Pipeline™ embolization device is used to treat adults 22 years of age and older who suffer from large aneurysms in the head and internal carotid artery. The second generation Pipeline™ device is not affected by this recall, but the first generation Pipeline™ device is affected because of its the PTFE coated delivery wire.

The UltraFlow™ flow directed micro catheter is used to deliver physician-specified therapeutic agents like diagnostic materials in tortuous, distal vessels. The Marathon™ Flow Directed Micro Catheter is used for infusing diagnostic and therapeutic materials into the peripheral and neuro-vasculature.

What Patients Can Do

Patients should make themselves aware of the recall and monitor their health for anything deviating from normal. In particular, they should be familiar with the signs of an embolism, which include the following:

  • Shortness of breath
  • Sharp chest pain
  • Rapid breathing
  • Rapid heart beat
  • Anxiety
  • Sweating
  • Fainting

If they experience any of the above symptoms, immediate medical help is crucial. Delay in treatment can lead to a serious medical condition or even death.

What Doctors Can Do

Doctors should make themselves aware of the potentially dangerous situation that may occur with use of these devices. They should be aware of the signs of an embolism, which are listed above. Patients with these symptoms should be treated as an emergency.

Any adverse events that occur due to use of the affected devices should be reported to the FDA. A report can be submitted online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Forms can be requested by calling 1-800-332-1088. Doctors can also contact the Medtronic Lifeline Service for more information by calling 1-877-526-7890.

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