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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER VENTRICULAR (ASSISST) BYPASS

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HEARTWARE INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1420
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE INC.
14400 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE INC.
14400 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14775751
Report Number3007042319-2022-05478
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model Number1420
Device Catalogue Number1420
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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