Spectranetics Corp. is recalling its Bridge Occlusion Balloon Catheter, used to temporarily block the superior vena cava (SVC) when emergency control of hemorrhage is required, because of a defect that may delay life-saving treatment, which may result in immediate and serious health consequences, including death.
The SVC is a large vein that carries deoxygenated blood from the head, arms and upper body into the heart.
The Spectranetics Bridge Occlusion Balloon Catheter is constructed of a compliant balloon mounted on a dual lumen shaft. The guidewire lumen is used to pass the catheter over a guide wire. The recall is being initiated because there is a risk that the guidewire lumen may be blocked in some device units. If used during a procedure, the device would not be positioned correctly and bleeding would not be controlled, which may lead to deadly consequences.
Spectranetics issued “Urgent Medical Device Recall” letters to affected customers informing them of the issue, and directed physicians to confirm that the guidewire lumen is open and unblocked prior to starting the procedure, and to have backup units on hand should they be needed during the procedure. The company issued a follow-up letter with additional recommendations for physicians.
The issue affects hospitals and health care professionals performing lead extraction surgery using a Spectranetics Bridge Occlusion Balloon Catheter manufactured between Feb. 13 and July 18, 2017, as well as patients undergoing procedures during that time period.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice