Devices

Device Recall Mach 1 6F 3.5 JR curve style Guide Catheter

Model / Serial
Product UPN H749343566850, Lot # 6287583
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
Product Description
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
Manufacturer
Boston Scientific Scimed
1 Event
- Recall of Device Recall Mach 1 6F 3.5 JR curve style Guide Catheter

Manufacturer

Boston Scientific Scimed

Manufacturer Address
Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
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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