PressureWire™ C12008Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734055758), received between Nov 27, 2019 and Sep 24, 2022 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Difficult to Insert; Use of Device Problem; No Apparent Adverse Event; Difficult to Insert; Use of Device Problem; No Apparent Adverse Event

  DURING THE PROCEDURE, AN EXPIRED CATHETER WAS USED. THE CATHETER WAS USED TO BE IMPLANTED IN LCX WITH HEAVY TORTUOSITY AND CALCIFICATION. IT WAS FOUND THAT IT WAS UNABLE TO CROSS THE LESION BEFORE IMPLANTING THE STENT. THE FAILURE TO CROSS THE LESION WAS DUE TO THE PATIENT ANATOMY AND NOT DUE TO THE INTERACTION OF DEVICES. NO RESISTANCE WAS FELT DURING THE PROCESS. NO OTHER DEVICE ISSUES OR PROCEDURE ISSUES WERE NOTED. THE CATHETER WAS EXCHANGED WITH THE SAME SIZE AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476032 ↗
• MalfunctionJul 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF THE EVENT OBSERVED DURING ANALYSIS, FRACTURE OF THE DEVICE INSIDE THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118594 ↗
• MalfunctionJan 6, 2022Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, AN EXPIRED DEVICE WAS INADVERTENTLY USED. ULTIMATELY THE DEVICE ENDED UP BEING EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175114 ↗
• MalfunctionDec 27, 2021Material Separation; Material Separation

  DURING THE PROCEDURE, IT WAS NOTED THAT THE A PORTION OF THE GUIDEWIRE DETACHED FROM THE DEVICE. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087786 ↗
• MalfunctionJun 15, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING DEVICE FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998464 ↗
• MalfunctionMay 17, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832675 ↗
• MalfunctionMay 14, 2021Difficult to Insert; Difficult to Insert

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826361 ↗
• MalfunctionMar 19, 2021Fracture; Communication or Transmission Problem; Fracture; Communication or Transmission Problem

  THIS EVENT IS BEING REPORTED DUE TO A FRACTURED GUIDEWIRE NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529248 ↗
• MalfunctionFeb 16, 2021Communication or Transmission Problem; Communication or Transmission Problem

  ONLY THE FRACTIONAL FLOW RESERVE PORTION OF THE PERCUTANEOUS CORONARY INTERVENTION WAS CANCELLED DUE TO THE SIGNAL LOSS. THE PROCEDURE WAS COMPLETED WITHOUT FRACTIONAL FLOW RESERVE MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331699 ↗
• MalfunctionFeb 1, 2021Connection Problem; Connection Problem

  DURING THE PROCEDURE, THE CONDUIT WAS UNABLE TO BE CONNECTED DURING USE OF THE PRESSURE WIRE AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263043 ↗
• InjuryDec 1, 2020Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A MEASUREMENT WAS UNABLE TO BE TAKEN DUE TO SIGNAL LOSS. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

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

  MAUDE report 10929376 ↗
• MalfunctionAug 19, 2020Material Separation; Material Separation

  DURING THE PROCEDURE, THE DEVICE FRACTURED INSIDE THE PATIENT'S ANATOMY AND THE SIGNAL WAS LOST. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426879 ↗
• InjuryNov 27, 2019Fracture; Material Separation; Fracture; Material Separation

  DURING THE PROCEDURE, THE DISTAL TIP OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. FFR EVALUATION WAS PERFORMED ON THE PATIENT AFTER CORONARY STENTING, AND AFTER ENTERING THE DISTAL DIAGONAL BRANCH, THE DISTAL TIP BROKE WHEN TRYING TO WITHDRAW THE DEVICE. A MICROCATHETER AND CATHETER EXTENSION WERE USED TO TRY TO PUSH THE GUIDEWIRE TO THE DISTAL END OF THE DIAGONAL BRANCH WITHOUT SUCCESS. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE DISTAL TIP OF THE GUIDEWIRE REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9383452 ↗