PressureWire™ C12009Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05415067025739), received between Jun 28, 2018 and Apr 8, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 3, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THE PRESSUREWIRE X CABLED OUTSIDE PACKAGE AND INNER PACKAGE WERE TORN. STERILITY WAS COMPROMISED, THEREFORE THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242053 ↗
• MalfunctionJan 13, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE PRESSUREWIRE X, THE DEVICE COULD NOT BE CONNECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. RETURN DEVICE ANALYSIS NOTED THE DISTAL TUBE MATERIAL WAS TORN AND BUNCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163109 ↗
• MalfunctionJan 5, 2023Material Separation; Communication or Transmission Problem; Material Separation; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PRESSUREWIRE X WAS ADVANCED INTO THE PATIENT HOWEVER THE DEVICE COULD NOT BE CONNECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. RETURN DEVICE ANALYSIS NOTED THE DISTAL CORE AND COILS WERE SEPARATED. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102758 ↗
• MalfunctionDec 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Material Separation; Incorrect, Inadequate or Imprecise Result or Readings; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 70% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PRESSUREWIRE X CABLED WAS CALIBRATED AND EQUALIZED; HOWEVER, THE SIGNAL DRIFT AFFECTED THE DATA ACCURACY. THE PAL LIGHTING COLOR PATTERN AT THE MOMENT OF THE FAILURE WAS BLINKING GREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW PRESSUREWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE PROXIMAL TUBE WAS BROKEN 1MM DISTAL TO THE SENSOR ASSEMBLY EXPOSING THE MICROCABLES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964606 ↗
• MalfunctionMay 31, 2022Improper or Incorrect Procedure or Method; Communication or Transmission Problem; Improper or Incorrect Procedure or Method; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PRESSUREWIRE X COULD NOT BE CALIBRATED DESPITE MULTIPLE ATTEMPTS. THE LIGHT WAS FLASHING GREEN ON THE TRANSMITTER. RESTARTING THE SYSTEM AND RE-INSERTING THE WIRE IN THE CABLE BOX DID NOT RESOLVE THE ISSUE. NO PATIENT WAS INVOLVED. THE PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE WAS COMPLETED WITHOUT FRACTIONAL FLOW RESERVE. NO ADDITIONAL INFORMATION WAS PROVIDED. ABBOTT VASCULAR IDENTIFIED THAT THIS DEVICE EXPIRED (B)(6) 2022. ALTHOUGH NO PATIENT WAS INVOLVED, THIS DEVICE WAS INTENDED TO BE USED IN THE PATIENT AFTER THE LABELED EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14551618 ↗
• MalfunctionFeb 23, 2022Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT DURING AN RFR [RELATIVE FLOW RESERVE] GUIDED ANGIOPLASTY, DIFFICULTY ACCESSING THE CORONARY ARTERY WITH THE PRESSUREWIRE X WIRELESS DEVICE WAS NOTED BECAUSE THE GUIDE CATHETER DID NOT PROVIDE ENOUGH SUPPORT. THE GUIDE CATHETER WAS EXCHANGED AND WHEN PASSING THE PRESSUREWIRE X WIRELESS DEVICE, THE POLYMER COATING HAD COME LOOSE / UNSTABLE LEAVING THE GUIDE CORE EXPOSED FROM THE MIDDLE TO PROXIMAL END. A NEW PRESSUREWIRE X WIRELESS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588345 ↗
• MalfunctionAug 19, 2020Material Separation; Communication or Transmission Problem; Material Separation; Communication or Transmission Problem

  DURING THE PROCEDURE, THE DEVICE FRACTURED INSIDE THE PATIENT'S ANATOMY AND LOST SIGNAL BEFORE EQUALIZATION COULD BE PERFORMED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425738 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIP OF THE DEVICE DID NOT BREAK. DURING THE PROCEDURE, AFTER THE DEVICE WAS INSERTED INTO THE PATIENT, THE SIGNAL WAS LOST. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752684 ↗
• InjuryJul 25, 2018Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PRESSUREWIRE X, CABLED WAS CALIBRATED AND EQUALIZED NORMALLY. WHILE ADVANCING THE DEVICE INTO THE LESION, THE RADIOPAQUE TIP PART (3CM) GOT BENT AND BECAME UNABLE TO BE REMOVED FROM THE LESION WITH MODERATE TORTUOSITY AND MILD ANGULATION. 50% STENOSIS WAS OBSERVED BY CAG NEAR LAD#6 MID, AND FFR MEASUREMENT WAS ATTEMPTED IN ORDER TO DIAGNOSE AND DEFER PCI. SINCE A 4FR CAG CATHETER WAS USED VIA THE RIGHT RADIAL, A 6FR GUIDING CATHETER WAS NEWLY ENGAGED FROM THE RIGHT INGUINAL REGION AND A NON-ABBOTT GUIDEWIRE WAS RE-CROSSED. DILATATION IN THE LESION WITH A BALLOON WAS PERFORMED, BUT THE DEVICE COULD NOT BE REMOVED. THE DEVICE WAS REMOVED BY FORCE AND THE PROCEDURE WAS COMPLETED WITHOUT FFR. NO FRAGMENTS REMAINED IN THE PATIENT. NO CONSEQUENCES OCCURRED ON THE PATIENT. ADDITIONAL INFORMATION IS NOT EXPECTED. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719201 ↗
• InjuryJun 28, 2018Material Fragmentation; Sticking; Material Fragmentation; Sticking

  THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A PRESSURE WIRE X, CABLED. FOLLOWING PRE-DILATATION, A STENT (3.5X15MM XIENCE SIERRA) WAS DEPLOYED AND POST-DILATED WITH A BALLOON CATHETER. IT IS UNKNOWN WHEN THIS OCCURRED, BUT PLAQUE SHIFTED INTO THE DIAGONAL ARTERY. THE PRESSURE WIRE X, CABLED WAS ADVANCED TO THE DIAGONAL ARTERY; HOWEVER, IT BECAME CAUGHT IN THE DEPLOYED STENT. THE DEVICE WAS PULLED BACK, BUT THIS CAUSED THE STENT TO ALSO PULL BACK INTO THE LEFT MAIN AND AORTA. THE TIP OF THE DEVICE UNRAVELED AND SEPARATED. THE SEPARATED PORTION OF THE TIP OF THE WIRE REMAINED ATTACHED TO THE STENT. AN ATTEMPT TO SNARE THE STENT WAS MADE, BUT UNSUCCESSFUL. AN ATTEMPT TO ADVANCE A 1.2MM BALLOON CATHETER OVER THE NATIVE LAD UNSPECIFIED WIRE WAS MADE; HOWEVER, THE BALLOON COULD NOT ADVANCE ON THE WIRE. AN ATTEMPT TO REMOVE THE STENT WITH A BUDDY WIRE SYSTEM WAS MADE BUT ALSO FAILED. ANOTHER ATTEMPT TO ADVANCE THE 1.2MM UNSPECIFIED BALLOON CATHETER ON THE WIRE WAS MADE BUT FAILED. AN ATTEMPT TO REMOVE THE STENT WITH A MICRO-CATHETER AND DOTTERING TECHNIQUE WAS MADE, BUT FAILED. THE STENT WAS CRUSHED INTO THE LEFT MAIN WITH 1.2MM, 2.0MM, AND 3.0MM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645544 ↗