Devices

Device Recall Coronary sinus catheter

Model / Serial
Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The Steerable Coronary Sinus Catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
Manufacturer
Edwards Lifesciences Llc
1 Event
- Recall of Device Recall Coronary sinus catheter

Manufacturer

Edwards Lifesciences Llc

Manufacturer Address
Edwards Lifesciences Llc, 12050 Lone Peak Parkway, Draper UT 84020-9414
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
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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