Medtronic Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters
Medtronic has issued a voluntary recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices.
Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient, which could lead to a thromboembolic event. Such events can include a clot in a vessel that leads to the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg. There is a significant risk of catastrophic injury or death should this occur.
This recall relates to the following products:
- Pipeline Embolization Device
- Alligator Retrieval Device
- X-Celerator Hydrophilic Guidewire
- Ultraflow and Marathon Flow Directed Micro Catheters
According to Medtronic, 84,278 devices are potentially affected by this recall, which had been distributed worldwide. The products were manufactured from July 2014 to September 2016.
Read the MedWatch safety alert, including a link to the press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm525672.htm
If you or a loved one have been injured by any of these devices contact one of our experienced product liability attorneys today.
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