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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSPHERE MEDICAL S.A. EMBOSPHERE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BIOSPHERE MEDICAL S.A. EMBOSPHERE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Catalog Number S620GH/C
Medical Device Problem Codes Fluid/Blood Leak (1250); Product Quality Problem (1506)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/06/2024
Type of Reportable Event Malfunction
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Brand Name
EMBOSPHERE
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BIOSPHERE MEDICAL S.A.
parc des nations paris nord 2
383 rue de la belle etoile
roissy-en-france, 95700
FR  95700
Manufacturer (Section G)
BIOSPHERE MEDICAL S.A.
parc des nations paris nord 2
383 rue de la belle etoile
roissy-en-france, 95700
FR   95700
Manufacturer Contact
marie-laure patucca
parc des nations paris nord 2
383 rue de la belle etoile
roissy-en-france, 95700
FR   95700
MDR Report Key25841917
Report Number9615728-2026-00014
Device Sequence Number18750644
Product Code KRD
UDI-Device Identifier00884450403440
UDI-Public00884450403440
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K181300
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/16/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/26/2025
Device Catalogue NumberS620GH/C
Device Lot NumberX2494386-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2024
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2024
Initial Report FDA Received Date07/16/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured09/19/2022
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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