FDA Recalls Terumo Medical Balloon Devices

WASHINGTON, D.C. — The U.S. Food and Drug Administration published an announcement that the agency issued a Class I recall of Terumo Medical Balloon devices used in heart surgery. The FDA’s designation of a Class I recall indicates that the medical devices at issue threaten to cause severe injury or death to the patient. According to a report appearing in Healio, 3,474 transfemoral systems are part of this recall. Every one of the 3,474 transfemoral systems was made and distributed from June 22, 2016, through March 3, 2019. The FDA is aware of two injuries and 14 complaints of device malfunctions. The FDA has not attributed the malfunctioning device to the death of any patient at this time.

Terumo Medical’s SoloPath transfemoral introducer system and re-collapsible recall system is a balloon-inflated device that surgeons insert into a patient’s femoral artery during particular heart procedures. Terumo Medical recalled all of the lots manufactured because the company learned that the tip of the sheath of the device could become displaced during the insertion process. As a result, the patient could sustain serious, life-threatening vascular injuries such as tearing, so-called pseudoaneurysms, and other severe injuries.

Doctors use the SoloPath device to aid insertion of catheters in the femoral or iliac arteries during heart surgery such as transcatheter aortic valve replacement surgery and associated procedures. Terumo Medical designed the device to help reduce friction during the catheter insertion process.

Terumo Medical initiated a voluntary recall after learning about the malfunctioning device. The medical device maker announced on April 30, 2019, that the company is discontinuing the product and asked doctors to complete the relevant reports. Terumo Medical urged surgeons to use other devices when performing heart procedures.

The nature of the injuries attributed to the failed device is not known at this time. Additionally, there was no information provided about how doctors learned about the 12 malfunctions that did not cause any injuries. Anyone with questions or concerns about the Terumo Medical recall should contact their healthcare providers.

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