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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER

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MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number SFR4-6-40-10
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2022
Event Type  malfunction  
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Brand NameSOLITAIRE FR4
Type of DeviceCATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key15234334
Report Number2029214-2022-01378
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K183022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSFR4-6-40-10
Device Catalogue NumberSFR4-6-40-10
Device Lot NumberB362717
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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