DxTerity™ TRA U5TRAN35SHARecalls & reported problems
Medtronic, Inc. · CATH U5TRAN35SHA DXT 5F 5PK 110CM TRN35 · Class 2
All models of DxTerity TRA (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169738775), received between May 24, 2018 and May 24, 2018 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K161287); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A DXTERITY DIAGNOSTIC CATHETER WAS USED DURING A NORMAL HEART CATH PROCEDURE. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NO ALLEGED PRODUCT MALFUNCTION IS REPORTED. THE VESSEL ASSOCIATED WITH THE EVENT HAD MILD CALCIFICATION AND MILD TORTUOUSITY. AFTER THE PROCEDURE THE PATIENT BECAME LETHARGIC. MRI SHOWED SHOWED STROKE FROM RIGHT CAROTID SIDE WHICH IS THE SIDE THAT THE CATHETER WAS INTRODUCED. PATIENT FULLY RECOVERED.
Patient problems: Stroke/CVA
MAUDE report 7540197 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161287. One submission often covers many models, so check the product and lot details in each record.
- Z-3253-2018 · Aug 16, 2018 · TerminatedMedtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
- Z-1479-2018 · Mar 13, 2018 · TerminatedMedtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
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- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H749085263001Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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