Devices

Device Recall Crimper

Model / Serial
lot 59617777 and 59658495.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Crimper Model 9100CR26 || The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Manufacturer
Edwards Lifesciences, LLC
1 Event
- Recall of Device Recall Crimper

Manufacturer

Edwards Lifesciences, LLC

Manufacturer Address
Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, 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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