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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 7.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 7.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4247040W
Device Problems Balloon; Shaft; Difficult to Remove ; Detachment of Device or device Component; Catheter
Event Date 04/06/2020
Event Type  Malfunction  
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Brand NameAVIATOR PLUS .014 7.0X40 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key10017580
Report Number9616099-2020-03682
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4247040W
Device Catalogue Number4247040W
Device LOT Number17718330
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/19/2017
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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