DxTerity™ DXT5PIGSTARecalls & reported problems
Medtronic, Inc. · CATH DXT5PIGSTA DXT 5F 5PK 110CM PGSTR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169689558), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2021Use of Device Problem; Use of Device Problem
A DEXTERITY CORONARY DIAGNOSTIC CATHETER WAS USED TO TREAT A LESION IN THE RCA. THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED WHEN USED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12335394 ↗
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.
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page