PressureWireRecalls & reported problems across all models

We found 2 models of PressureWire by Lightlab Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 307 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Sep 30, 2026 — classified as 1 death, 103 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Material Separation” (122 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PressureWire problems

PressureWire models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PressureWire™ C12059

  WIRE, GUIDE, CATHETER
  1 death296 reports
• PressureWire™ C12009

  WIRE, GUIDE, CATHETER
  11 reports

Recent PressureWire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult or Delayed Positioning; Device Difficult to Setup or Prepare

  Reportedly, while advancing the PressureWire X - Wireless device, poor torque transmission was noted. The torque device was retightened; however, the torque device remained loose and torque control could not be achieved. Another PressureWire X - Wireless device was used to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947611 ↗
• MalfunctionSep 29, 2026Material Separation; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936467 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936278 ↗
• MalfunctionSep 24, 2026Break; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888703 ↗
• MalfunctionAug 21, 2026Connection Problem

  From Staff: Inserted a pressure wire into the LAD "[left anterior descending]" vessel. Was able to equalize and pair, wire was placed in appropriate position per the physician, went to snap the recording and pressure wire was no longer connected. Attempted to reconnect, would not work. Had to remove pressure wire from body and use a new one which worked without issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378930 ↗
• MalfunctionAug 14, 2026Particulates; Difficult to Remove; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254109 ↗
• MalfunctionMay 7, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PRESSUREWIRE X WIRELESS DEVICE WAS INTENDED TO BE USED IN A LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. IT WAS NOTED A LESS THAN 6F SHEATH WAS USED. DURING ADVANCEMENT, THE DEVICE DID NOT ADVANCE SMOOTHLY WHEN PUSHED, AND RESISTANCE WAS NOTED DURING WITHDRAWAL. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE X DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117004 ↗
• MalfunctionMay 7, 2026Break; Deformation Due to Compressive Stress; Communication or Transmission Problem

  REPORTEDLY, THE PWX DEVICE WAS CALIBRATED AND EQUALIZATION WAS SUCCESSFUL. WHILE ADVANCING THE DEVICE TO THE TARGET LESION, THE DEVICE BECAME KINKED AND THE SIGNAL WAS LOST. THE TRANSMITTER WAS STEADY YELLOW. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DURING PRODUCT RETURN INVESTIGATION, THERE WAS A BREAK IN THE PROXIMAL TUBE AT THE NOTED KINK, EXPOSING THE COREWIRE. THE ACCOUNT CONFIRMED THE BREAK WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112539 ↗
• MalfunctionApr 23, 2026Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE DEVICE WAS STRETCHED, UNRAVELED DUE TO RESISTANCE WITH STENT PLACEMENT. ALSO, THERE WAS RESISTANCE DURING REMOVAL. THE CORE WAS SEPARATED BUT HELD TOGETHER BY THE COILS. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961521 ↗
• InjuryApr 15, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT CIRCUMFLEX (LCX) LESION. IT WAS NOTED THE VESSEL ITSELF WAS HEAVILY CALCIFIED AND TORTUOUS/KINKED. IT WAS DIFFICULT TO REMOVE AND DIFFICULT TO ADVANCE DUE TO THE ANATOMY. HOWEVER, DURING INTERVENTION, THE TIP WAS TORN/RIPPED OFF. THE TIP WAS STENTED INTO THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24888946 ↗
• MalfunctionApr 8, 2026Difficult to Remove; Communication or Transmission Problem; Material Split, Cut or Torn

  REPORTEDLY, TWO PRESSUREWIRE X (PWX) WIRELESS DEVICES (51122G1) WERE USED DURING THE PROCEDURE. THE FIRST PWX WAS DIFFICULT TO REMOVE FROM THE HOOP DURING PREPARATION. AFTER REMOVAL FROM THE HOOP, THE DEVICE WAS CALIBRATED AND EQUALIZATION WAS SUCCESSFUL. AFTER EQUALIZATION, THERE WAS NO GREEN PRESSURE CURVE PRESENT, AND THE TRANSMITTER WAS GREEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE CONTINUED WITH THE SECOND DEVICE. THE SECOND PWX DEVICE COULD NOT BE EQUALIZED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT A REPLACEMENT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION, THE DISTAL TUBE HAD CUTS AND TEARING OF THE POLYIMIDE TUBING ALONG ITS ENTIRE LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821584 ↗
• MalfunctionApr 8, 2026Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE PRESSUREWIRE X, CABLED DEVICE HAD NO SIGNAL AND CALIBRATION WAS UNSUCCESSFUL. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND ANOTHER PRESSUREWIRE X, CABLED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE DISTAL TUBE WAS KINKED 3.4 CENTIMETERS PROXIMAL TO THE DISTAL TIP. THE DISTAL TUBE WAS TORN AT THE NOTED KINK, EXPOSING THE MICROCABLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818490 ↗
• MalfunctionApr 3, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings

  REPORTEDLY, THE PWX DEVICE WAS CALIBRATED AND EQUALIZATION WERE SUCCESSFUL. HOWEVER, A DRIFT OCCURRED DURING THE PROCEDURE. THE TRANSMITTER WAS GREEN. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PWX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION AND AFTER CLEANING, THE SENSOR WAS RE-EXAMINED, REVEALING A BREAK IN THE SENSOR PAD MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774958 ↗
• MalfunctionMar 30, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PRESSUREWIRE X WIRELESS DEVICE WAS REMOVED FROM THE PACKAGE WHEN IT WAS NOTED AS KINKED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRODUCT RETURN IDENTIFIED A BREAK IN THE PROXIMAL TUBE OF THE PRESSUREWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716811 ↗
• MalfunctionMar 26, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings

  REPORTEDLY, THE PWX DEVICE WAS CALIBRATED SUCCESSFULLY. HOWEVER, THE PRESSURE SIGNAL WAS UNSTABLE, AND EQUALIZATION COULD NOT BE ACHIEVED. THE TRANSMITTER WAS GREEN. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER PRESSUREWIRE X, WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION, A BREAK WAS NOTED IN THE PRESSURE SENSOR MEMBRANE IN THE SENSOR CHIP ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699050 ↗

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