PressureWire™ C12059Recalls & reported problems

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 05415067025715), received between Jul 2, 2018 and Sep 30, 2026 — classified as 1 death, 101 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Material Separation” (118 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 25 most recent of 296 reports, 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 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 ↗
• MalfunctionMar 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN AN UNSPECIFIED ARTERY. THE PRESSUREWIRE X WIRELESS GUIDEWIRE DID NOT CONNECT WITH THE PA (AORTIC PRESSURE) FAILING TO EQUALIZE. ANOTHER PRESSUREWIRE X WIRELESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. HOWEVER, THE DEVICE WAS NOTED TO BE EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666172 ↗
• InjuryMar 19, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, IT WAS DIFFICULT TO REMOVE THE DEVICE FROM THE HOOP. ALSO, DURING FFR MEASUREMENT, THE WIRE TIP BROKE OFF IN THE PROXIMAL LAD AND COULD NOT BE RETRIEVED. THE BROKEN TIP WAS STENTED INTO THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24638589 ↗
• MalfunctionMar 17, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings

  REPORTEDLY, THE PWX DEVICE WAS CALIBRATED AND EQUALIZATION WERE SUCCESSFUL. HOWEVER, THE PRESSURE VALUES DISPLAYED WERE FOUND TO BE HIGHER AND INACCURATE (THE PRESSURE WAS 120/60, IT SHOWED 180/12). THE TRANSMITTER LIGHT 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 24618397 ↗
• MalfunctionMar 17, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings

  REPORTEDLY, THE PWX DEVICE WAS CALIBRATED SUCCESSFULLY. WHILE ATTEMPTING EQUALIZATION, THERE WAS A LARGE DIFFERENCE BETWEEN THE PA AND PD VALUE, AND EQUALIZATION COULD NOT BE ACHIEVED. 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, IT WAS OBSERVED THAT THERE WAS A BREAK IN THE PRESSURE SENSOR MEMBRANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618010 ↗
• MalfunctionMar 13, 2026Break; Incorrect, Inadequate or Imprecise Result or Readings; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE CALIBRATED AND EQUALIZED SUCCESSFULLY. THE DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD). HOWEVER, THE DEVICE FAILED TO READ PROPERLY AT A >1.0. THE TRANSMITTER LIGHT WAS STEADY 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. RETURNED DEVICE ANALYSIS FOUND THE DISTAL TUBE WAS TORN 6 MM FROM THE PROXIMAL END OF THE DISTAL TUBE FOR A LENGTH OF 3.3 CM. A PORTION OF THE TORN DISTAL TUBE ALSO MEASURING 3.3 CM WAS SEPARATED BUT RETURNED WITH THE PRESSUREWIRE. THE MICROCABLES WERE SEPARATED AT THE NOTED TEAR BUT HELD TOGETHER BY THE CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592561 ↗
• MalfunctionMar 13, 2026Difficult to Remove

  REPORTEDLY, THE PRESSUREWIRE X - WIRELESS DEVICE WAS DIFFICULT TO REMOVE FROM THE HOOP DURING PREPARATION. AFTER REMOVAL, THE DEVICE WAS ADVANCED TOWARDS THE LESION, HOWEVER, THE TIP OF THE DEVICE BECAME STUCK IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND RESISTANCE WAS FELT WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT'S ANATOMY. 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 24589375 ↗
• MalfunctionMar 9, 2026Material Separation; Failure to Advance

  IT WAS REPORTED THAT DURING DELIVERY OF THE PRESSUREWIRE X (PWX) TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY TARGET LESION, RESISTANCE WAS MET, POSSIBLY DUE TO THE TORTUOUS ANATOMY. IT WAS ALSO POSSIBLE THAT THE RESISTANCE WAS WITH THE GUIDE CATHETER ITSELF (TWO SIDE HOLES, SO IT IS ALSO POSSIBLE THAT THE PWX MAY HAVE PASSED THROUGH A SIDE HOLE, RESULTING IN THE LOSS OF TORQUE CONTROL.) THE TORQUE RESPONSE BECAME INEFFECTIVE PARTWAY THROUGH ADVANCEMENT, AND THE PWX COULD NOT REACH THE TARGET LESION IN THE MID LAD. DURING ADVANCEMENT OF THE PWX, THE GUIDING CATHETER (GC) JUMPED. THE PWX WAS VISUALIZED IN THE AORTA AT THIS POINT. UPON WITHDRAWING THE PWX, A WIRE BREAK (FRACTURE) WAS NOTED APPROXIMATELY 30 CM FROM THE DISTAL TIP (BETWEEN THE GOLD SECTION AND THE GREEN PTFE COATING OF THE PWX), WITH THE DISTAL FRAGMENT REMAINING ATTACHED TO THE GUIDING CATHETER. AFTER THE GUIDING CATHETER WAS CAREFULLY REMOVED FROM THE BODY, THE DISTAL FRAGMENT OF THE PWX WAS REMOVED TOGETHER WITH IT, WITHOUT RESISTANCE. ONCE OUTSIDE THE BODY, THE PWX DISTAL FRAGMENT DETACHED FROM THE GUIDING CATHETER. THE LESION WAS RE-IMAGED USING THE SAME GUIDING CATHETER, AND SINCE NO SIGNIFICANT ISSUES W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549879 ↗
• MalfunctionMar 5, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  THE PWX DEVICE WAS USED DURING THE PROCEDURE, HOWEVER, AN UNKNOWN ERROR OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION, FURTHER INSPECTION REVEALED THE PRESSURE SENSOR PAD IN THE SENSOR CHIP ASSEMBLY WAS CUT/TORN DIAGONALLY ACROSS THE PAD, RESULTING IN FAULTY PRESSURE REGISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524495 ↗
• InjuryMar 5, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, DURING ADVANCEMENT THE WIRE GOT STUCK AND BROKE OFF; THE USER JAILED THE TIP OF THE WIRE IN THE STENT. THE WIRE WAS REMOVED AND THE TINY PIECE OF THE WIRE THAT BROKE OFF WAS STENTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24518929 ↗
• InjuryFeb 24, 2026Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THE DEVICE GOT STUCK IN A 70% CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION AND WAS DIFFICULT TO REMOVE WHEN THE WIRE WAS PULLED BACK. A RUN THROUGH WIRE WAS PLACED DISTAL TO IT AND PULLED BACK BUT THE WIRE TIP FRACTURED. A SECOND RUN THROUGH WIRE WAS USED TO TWIST BOTH DEVICES TO TRAP THE FRACTURED TIP. THE TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS. HOWEVER, THERE WAS A DELAY WHEN THE TWO WIRES WERE SLIP DOWN AND TWIST THE "100" TIMES TO TANGLE UP THE WIRE TO REMOVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436319 ↗
• MalfunctionFeb 9, 2026Material Separation; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION WITH THE PRESSURE WIRE X, WIRELESS DEVICE, CONNECTION FAILED AND CALIBRATION WAS NOT PERFORMED. THE TRANSMITTER LIGHT WAS STEADY YELLOW. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS SHOWS THERE WAS A SEPARATION OF THE SENSOR CHIP ASSEMBLY. ONLY THE PROXIMAL SEGMENT OF THE CHIP ASSEMBLY REMAINED IN THE SENSOR JACKET. THE DISTAL SEGMENT WAS NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299474 ↗