DxTerity™ TRA U5TRAP35SHRecalls & reported problems
Medtronic, Inc. · CATH U5TRAP35SH DXT 5F 5PK 100CM TRP35 · Class 2
Data updated Oct 13, 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 00643169738478), received between Sep 8, 2017 and Sep 8, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
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, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE PHYSICIAN WAS USING A DEXTERITY DIAGNOSTIC CATHETER DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE CATHETER PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED PER IFU. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE CATHETER WAS USED IN THE PROXIMAL RCA, WHICH EXHIBITED SEVERE TORTUOSITY AND WAS NOT CALCIFIED. DURING USE OF THE DEXTERITY A SPIRAL DISSECTION OF THE RCA OCCURRED. THERE WAS NO LESION IN THE LOCATION OF THE DISSECTION. THE PATIENT WAS SENT FOR BYPASS SURGERY AS THE PHYSICIAN WAS UNABLE TO GET WIRE THROUGH THE DISSECTION TO TREAT THIS AE. IT IS REPORTED THAT PATIENT IS DOING FINE POST PROCEDURE.
Patient problems: Intimal Dissection; Patient Problem/Medical Problem
MAUDE report 6851351 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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