OmniWire Pressure guide wireRecalls & reported problems across all models

We found 2 models of OmniWire Pressure guide wire by Philips Image Guided Therapy Corporation in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Sep 2, 2020 and Sep 17, 2026 — classified as 1 death, 43 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (80 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 still open.

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

OmniWire Pressure guide wire recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 1, 2025Class IIOpen, Classified

   Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

   Z-1660-2025 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

2. May 16, 2022Class IITerminated

   Due to a potential failed sterilization process.

   Z-1270-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported OmniWire Pressure guide wire problems

OmniWire Pressure guide wire models

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

• OmniWire Pressure guide wire 89185

  Wire, Guide, Catheter
  1 recall1 death160 reports
• OmniWire Pressure guide wire 89185J

  Wire, Guide, Catheter
  2 recalls31 reports

Recent OmniWire Pressure guide wire adverse event reports

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

• InjurySep 17, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50805915 ↗
• MalfunctionAug 24, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419370 ↗
• MalfunctionAug 24, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419366 ↗
• InjuryJan 13, 2026Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE FOR A SEVERELY CALCIFIED DISTAL LAD. DURING USE, RECOGNITION WAS SUCCESSFUL; HOWEVER, THE TIP BECAME STUCK/ENTANGLED IN A DUCTAL BRANCH AND SEPARATED. AN EMERGENT SURGERY WAS PERFORMED TO REMOVE THE SEPARATED TIP. THE PHYSICIAN BELIEVED THIS WAS DUE TO THE UNIQUENESS OF THE SITUATION, AND NOT FROM A PRODUCT DEFECT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO TIP SEPARATION, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058654 ↗
• MalfunctionDec 30, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE. DURING USE, A NON-PHILIPS BALLOON WAS ADVANCED OVER THE WIRE. THE BALLOON WAS INFLATED/DEFLATED BUT WHEN IT WAS BEING REMOVED, IT GOT STUCK ON THE WIRE; THEREFORE, WAS REMOVED AS A UNIT. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE OMNIWIRE AND BALLOON WERE REMOVED AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928986 ↗
• InjuryDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN A SLIGHTLY CALCIFIED MID CIRC. DURING USE, APPROX. 3 CM OF THE DISTAL TIP SEPARATED IN THE BRANCH AND COULD NOT BE REMOVED WITH A SNARE; THEREFORE, WAS STENTED TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER AND THE PATIENT REMAINED STABLE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE OMNIWIRE SEPARATION; RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23889250 ↗
• InjuryDec 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE IN A CALCIFIED MID LAD. DURING USE, THE WIRE GOT STUCK ON SOME PLAQUE AND SEPARATED. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION, BUT UNABLE TO; THEREFORE, IT WAS STENTED TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS DOING WELL. THE PHYSICIAN BELIEVES THE CALCIUM IN THE VESSEL CAUSED THE MALFUNCTION. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE OMNIWIRE SEPARATION, REQUIRING INTERVENTION BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23767869 ↗
• MalfunctionDec 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE. DURING USE, THE DISTAL PORTION OF THE DEVICE SEPARATED WITHIN THE NON-PHILIPS INTRODUCER SHEATH; THEREFORE, BOTH WERE REMOVED TOGETHER WITH NO ADDITIONAL INTERVENTION. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE OMNIWIRE DISTAL PORTION SEPARATED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762382 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. PRIOR TO USE, THE OMNIWIRE WAS FLUSHED, THEN SHAPED WITH THE INTRODUCER TOOL, AS USUAL. DURING USE, RESISTANCE WAS NOTED NEAR THE SUBCLAVIAN, AND THE OMNIWIRE BUCKLED AND WOULD NOT ADVANCE FURTHER. THE OMNIWIRE WAS WITHDRAWN FROM THE NON-PHILIPS WATCHDOG HEMOSTASIS VALVE, WHEN A YELLOW PLASTIC STRING LIKE MATERIAL APPEARED TO HAVE BEEN STRIPPED OFF. UPON REMOVAL OF THE GUIDE CATHETER FROM THE PATIENT, NO KINKS, THROMBUS, OR RESIDUAL MATERIAL WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A J WIRE WITH NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, MISSING MATERIAL FROM THE CORE WIRE WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MISSING MATERIAL. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492564 ↗
• InjuryOct 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL LAD. DURING ADVANCEMENT, THE TIP OF THE WIRE COILED ON ITSELF, PREVENTING FURTHER ADVANCEMENT OR RETRACTION WITHOUT ENCOUNTERING RESISTANCE. THE DISTAL TIP SEPARATED, BUT A SNARE WAS USED TO SUCCESSFULLY RETRIEVE FROM THE PATIENT. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO TIP SEPARATION, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398528 ↗
• MalfunctionOct 23, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE IN THE PROXIMAL LAD. DURING USE, THE WIRE WAS RECOGNIZED BY THE SYSTEM BUT DRIFT WAS EXPERIENCED. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR A LATER. NO PATIENT INJURY WAS REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE OMNIWIRE COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373119 ↗
• InjuryOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE IN A MODERATELY CALCIFIED DISTAL LAD. DURING REMOVAL, THE OMNIWIRE SEPARATED DUE TO HEAVY CALCIUM AND TORTUOSITY. MULTIPLE ATTEMPTS USING ANOTHER WIRE AND BALLOON FOR REMOVAL WERE UNSUCCESSFUL; THEREFORE, THE SEPARATED PORTION WAS LEFT IN BODY WITHOUT STENTING. THE PROCEDURE WAS COMPLETED AND PATIENT IS DOING OK. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE OMNIWIRE SEPARATION; RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23353521 ↗
• InjuryOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN THE PROXIMAL LAD. PRIOR TO USING THE OMNIWIRE, A STENT WAS DEPLOYED IN THE PROXIMAL PART OF THE LAD. THEN, THE OMNIWIRE WAS SUPPOSED TO MEASURE THE STENOSIS IN THE DISTAL PART OF THE VESSEL BUT GOT STUCK ON THE STENT STRUT. THE DISTAL TIP SEPARATED AND REMAINED IN THE SMALL SIDE VESSEL OUTSIDE OF THE LAD; WITH NO ATTEMPTS TO REMOVE FROM THE PATIENT. THE PATIENT STAYED IN THE HOSPITAL AND CHECKED ON THE FOLLOWING DAY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION; RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23313300 ↗
• MalfunctionAug 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN AN EMERGENT CORONARY THERAPEUTIC PROCEDURE. DURING USE, THE OMNIWIRE WAVEFORM WAS FUZZY. THE PROCEDURE WAS COMPLETED WITH A NEW OMNIWIRE DEVICE, NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE OMNIWIRE COULD NOT BE USED DURING AN EMERGENT CASE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861928 ↗
• InjuryAug 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE. AFTER MEASUREMENT, THE DISTAL TIP SEPARATED IN THE LAD, AND TRAPPED WITH A STENT. THE PROCEDURE WAS COMPLETED USING ANGIO AND FLUORO. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION, BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22717649 ↗

Other Philips Image Guided Therapy Corporation products

• Visions PV .014P RX Digital IVUS Catheter2 models · 90 reports · 1 recall
• Visions PV .035 Digital IVUS Catheter2 models · 32 reports · 2 recalls
• Pioneer Plus Catheter2 models · 64 reports
• IntraSight Plus2 models · 0 reports · 1 recall
• Verrata Plus Pressure Guide Wire2 models · 45 reports