DxTerity™ TRA U6ULTRA40SHARecalls & reported problems
Medtronic, Inc. · CATH U6ULTRA40SHA DXT 6F 5PK 110CM UL40 · 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 00763000016791), received between Jul 29, 2019 and Jul 29, 2019 — 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
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A DXTERITY DIAGNOSTIC ANGIOGRAPHY CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 100% CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A DISSECTION OCCURRED DURING THE PROCEDURE. IT WAS INDICATED THAT THE CURVE OF THE DEVICE MAY HAVE CONTRIBUTED TO THIS EVENT.
Patient problems: Vascular Dissection
MAUDE report 8835192 ↗
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™ 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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