Devices

Device Recall IVUS Catheter

Model / Serial
Product Code PPLUS20; All lots
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
Product Description
Volcano Pioneer Plus Re-Entry Catheter; || Product Code PPLUS20, Catheter for Crossing Total Occlusions. || Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
Manufacturer
Volcano Corporation
1 Event
- Recall of Device Recall IVUS Catheter

Manufacturer

Volcano Corporation

Manufacturer Address
Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
Manufacturer Parent Company (2017)
Philips
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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