37 results
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33ms
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Sources: EU EUDAMED, US FDA
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·Xlumena, Inc.·September 18, 2013
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.
FDA Recall
Terminated
·Xlumena, Inc.·Product code GCJ·April 17, 2013
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·XLUMENA INC.·Product code PCU·November 12, 2014
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·XLUMENA INC.·Product code PCU·October 14, 2014
NAVIX ACCESS DEVICE
FDA Adverse Event
Injury
·XLUMENA, INC.·Product code GCJ·October 15, 2010
NAVIX ACCESS DEVICE
FDA Adverse Event
Injury
·XLUMENA INC.·Product code GCJ·August 22, 2011
NAVIX ACCESS DEVICE
FDA Adverse Event
Malfunction
·XLUMENA INC.·Product code GCJ·May 16, 2013
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Other
·XLUMENA, INC.·Product code PCU·July 29, 2014
NAVIX ACCESS DEVICE
FDA Adverse Event
Injury
·XLUMENA, INC.·Product code GCJ·April 4, 2011
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·XLUMENA INC.·Product code PCU·March 27, 2015
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·XLUMENA INC., A BOSTON SCIENTIFIC COMPANY·Product code PCU·June 16, 2015
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·XLUMENA INC., BOSTON SCIENTIFIC CO·Product code PCU·June 11, 2015
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 13, 2024
CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code KNS·August 13, 2024
AXIOS STENT AND DELIVERY SYSTEM
FDA Adverse Event
Death
·XLUMENA INC., BOSTON SCIENTIFIC CO·Product code PCU·June 16, 2015
BIOGLUE- UNKNOWN CONFIGURATION
FDA Adverse Event
Injury
·ARTIVION, INC.·Product code MUQ·April 26, 2024
OCTARAY MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code MTD·January 26, 2024
LASSOSTAR, 10P, DIA 15MM LOOP SIZE
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·May 16, 2023
IMPELLA
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 30, 2026
OCTARAY MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code MTD·November 4, 2025