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PressureWire™ C12058Recalls & reported problems

St. Jude Medical, Inc. · Guidewire Mounted Sensor · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734055772), received between Jul 2, 2019 and Apr 20, 2021 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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

  • Incorrect, Inadequate or Imprecise Result or Readings2
  • Adverse Event Without Identified Device or Use Problem1
  • Communication or Transmission Problem1
  • Difficult to Insert1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient2
  • Death1
  • Stroke/CVA1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 20, 2021Communication or Transmission Problem; Communication or Transmission Problem

    DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO EQUALIZE THE PRESSURE DUE TO SIGNAL LOSS, WHICH LED TO THE PROCEDURE BEING CANCELLED AND RESCHEDULED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11698377 ↗
  • MalfunctionFeb 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    RELATED MFR NUMBER: 3008452825-2020-00712. DURING PREPARATION FOR A CORONARY FLOW ASSESSMENT PROCEDURE, WHILE THE PATIENT WAS PREPPED, THE TIP OF THE GUIDEWIRE WAS SHAPED, HOWEVER WHEN INTRODUCING THE DEVICE, THE GUIDEWIRE WAS UNABLE TO BE EQUALIZED. THE DEVICE WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11333862 ↗
  • InjuryJan 4, 2021Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings; Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings

    DURING PREPARATION, THE TIP OF THE GUIDEWIRE WAS SHAPED, HOWEVER WHEN INTRODUCING THE DEVICE, THE GUIDEWIRE WAS UNABLE TO TAKE A READING. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 11107562 ↗
  • MalfunctionJan 13, 2020Fracture; Fracture

    THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9583493 ↗
  • DeathJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER A CORONARY INTERVENTION PROCEDURE, THE PATIENT SUFFERED A STROKE AND EXPIRED. FOLLOWING THE PROCEDURE, POST-ANGIOGRAPHY FFR WAS DONE FOR A LAD OSTIAL LESION. THE FFR WAS NEGATIVE WITH A VALUE OF .88. THE PATIENT WAS MOVED TO THE CCU AND FOUR HOURS POST-PROCEDURE, THE PATIENT WAS OBSERVED WITH A STROKE AND EXPIRED.

    Patient problems: Death; Stroke/CVA

    MAUDE report 8752696 ↗

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Sources and updates

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