Devices

Device Recall Lumen Biomedical Xtract Aspiration Catheter system

Model / Serial
Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.
Product Classification
Cardiovascular Devices
Distribution
Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria
Product Description
Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.
Manufacturer
Volcano Corporation
1 Event
- Recall of Device Recall Lumen Biomedical Xtract Aspiration Catheter system

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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