DxTerity™ TRA U5TRAP40SHRecalls & reported problems
Medtronic, Inc. · CATH U5TRAP40SH DXT 5F 5PK 100CM TRP40 · Class 2
All models of DxTerity TRA (9)
Data updated Oct 16, 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 00643169738560), received between Sep 8, 2017 and Sep 8, 2017 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intimal Dissection1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN WAS USING A DXTERITY DIAGNOSTIC CATHETER WHEN TREATING THE PROXIMAL LAD, MODERATE TORTUOSITY, NON-CALCIFIED, NO STENOSIS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT APPLIED. A DISSECTION OCCURRED NEAR THE LOCATION OF THE TIP OF THE CATHETER AND WAS TREATED WITH A RESOLUTE ONYX STENT. IT IS REPORTED THAT THE PHYSICIAN DOES NOT THINK THAT THE CATHETER CAUSED THE DISSECTION, BASED ON THE PATIENT'S CLINICAL SYMPTOMS, THIS DISSECTION MAY HAVE ALREADY BEEN THERE. NO OTHER DEVICE WAS IN THIS VESSEL. NO ADDITIONAL PATIENT CLINICAL SEQUELAE REPORTED.
Patient problems: Intimal Dissection; Patient Problem/Medical Problem
MAUDE report 6851125 ↗
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™ H74908526031Boston 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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