Devices

Device Recall ev3 Primus GPS Biliary Stent and Delivery System

Model / Serial
Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
Product Description
ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
Manufacturer
Ev3, Inc
1 Event
- Recall of Device Recall ev3 Primus GPS Biliary Stent and Delivery System

Manufacturer

Ev3, Inc

Manufacturer Address
Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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