International Medical Devices Database

Manufacturer Address
Orbus Medical Technologies Inc, 5363 NW 35th Ave, Fort Lauderdale FL 33309-6315
Source
USFDA
1 Event
- Recall of Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

One device in the database

Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

Model / Serial
Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026
Distribution
Product was shipped to one own label distributer in California.
Product Description
The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. || The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. || Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. || Ref. Baloon-Expandable Stent and delivery System. || Catalog Numbers || SD186U14D || SD186U24D || SD366U14D || SD366U24D

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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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Orbus Medical Technologies Inc

One device in the database

Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis