OmniWire Pressure guide wire 89185Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 00845225003043), received between Sep 2, 2020 and Aug 24, 2026 — classified as 1 death, 39 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (75 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K192886, K202543); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 1, 2025Open, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 25, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING USE, A SIGNAL WAS NOT DETECTED. THE WIRE WAS REMOVED AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, THE SENSOR WAS FOUND TO BE RAISED WITH A SHARP EDGE. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606819 ↗
• MalfunctionJun 18, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING THE FIRST MEASUREMENT, THE OMNIWIRE WORKED AS INTENDED. HOWEVER, WHEN PREPARING TO USE AGAIN, WHILE INSERTING THROUGH THE INTRODUCER NEEDLE, THE TIP OF THE WIRE LOOKED UNRAVELED. THEREFORE, A NEW OMNIWIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, IT WAS CONFIRMED THAT THE TIP COIL UNRAVELED BUT REMAINED INTACT. HOWEVER, THE CORE WIRE AND SHAPING RIBBON BROKE, EXPOSING SHARP EDGES. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284638 ↗
• MalfunctionJun 16, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING ADVANCEMENT, THE WIRE GOT STUCK IN THE MODERATELY CALCIFIED LESION. WHEN REMOVING THE WIRE TO RESHAPE, IT STARTED TO UNRAVEL BUT REMAINED INTACT. BY CHOICE, THE WIRE, INTRODUCER SHEATH, AND GUIDE CATHETER WERE REMOVED TOGETHER. DUE TO THE VESSEL BEING TOO CALCIFIED, THE USE OF THE WIRE WAS ABORTED. THE PATIENT WAS TREATED WITH MEDICINE WITH NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, IT WAS CONFIRMED THAT THE TIP COIL UNRAVELED BUT REMAINED INTACT. HOWEVER, THE CORE WIRE AND SHAPING RIBBON BROKE, EXPOSING SHARP EDGES. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212758 ↗
• MalfunctionMay 2, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN AN EMERGENT CORONARY DIAGNOSTIC PROCEDURE. DURING USE, THE CATHETER FAILED TO NORMALIZE, EVEN AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE, NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE WIRE 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 21953468 ↗
• InjuryApr 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE IN A SEVERELY CALCIFIED LAD. DURING USE, RESISTANCE WAS ENCOUNTERED, AND THE DISTAL TIP BROKE OFF INSIDE THE PATIENT. ATTEMPTS TO REMOVE THE SEPARATED PORTION WITH A SNARE WAS UNSUCCESSFUL; THUS, A TRIPLE BYPASS SURGERY WAS PERFORMED FOR REMOVAL. 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 21779235 ↗
• MalfunctionApr 4, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY PROCEDURE. DURING USE, THE WIRE WAS DEFECTIVE. IT IS UNKNOWN IF THE DEVICE WAS BEING USED IN AN EMERGENT PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE IT IS UNKNOWN IF THE FAILURE OCCURRED DURING AN EMERGENT PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778869 ↗
• MalfunctionMar 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE IN THE MID RCA. DURING USE, THE OMNIWIRE WAS UNABLE TO RECONNECT TO THE CONNECTOR BOX. UPON REMOVAL, A BENT WIRE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, A BEND AT THE COMPOSITE CORE WAS CONFIRMED WITH MISSING MATERIAL OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE MISSING MATERIAL. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708536 ↗
• MalfunctionMar 21, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. UPON REMOVAL FROM THE PATIENT, IT WAS OBSERVED THAT A PORTION OF THE COATING HAD PEELED AND DETACHED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE MATERIAL SEPARATION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663048 ↗
• MalfunctionMar 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING PREP, THE OMNIWIRE WAS PLACED THROUGH AN INTRODUCER NEEDLE AND THROUGH THE TUOHY THAT WAS CONNECTED TO A NON-PHILIPS GUIDE CATHETER. AFTER USE, WHEN THE OMNIWIRE WAS PULLED OUT OF THE GUIDE CATHETER AND THROUGH THE TUOHY, A GOLD SUBSTANCE HAD PEELED FROM THE MID/DISTAL PORTION THAT WAS WRAPPED AROUND THE OMNIWIRE. ALL PIECES WERE REMOVED INTACT WITH NOTHING REMAINING IN THE PATIENT. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE MATERIAL SEPARATION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578320 ↗
• MalfunctionMar 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. WHILE ADVANCING THE WIRE THROUGH A NON-PHILIPS GUIDE CATHETER, RESISTANCE WAS ENCOUNTERED. THE WIRE GOT STUCK INSIDE THE GUIDE CATHETER, AND BOTH WERE REMOVED AS A SYSTEM. UPON REMOVAL, THE WIRE UNRAVELED, BUT REMAINED INTACT. A NEW OMNIWIRE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE OMNIWIRE AND A GUIDE CATHETER 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 21577950 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE, IN A SEVERELY TORTUOUS AND SLIGHTLY CALCIFIED LAD. AFTER THE OMNIWIRE WAS DELIVERED TO THE LESION, A DISSECTION WAS NOTED IN THE MID LAD. HOWEVER, A STENT WAS USED SUCCESSFULLY TO TREAT THE DISSECTION. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE OMNIWIRE.

  Patient problems: Vascular Dissection

  MAUDE report 21552794 ↗
• InjuryFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED RCA. DURING USE, RESISTANCE WAS ENCOUNTERED IN THE OSTIUM OF THE RCA AND THE GUIDEWIRE GOT CAUGHT IN A STENT, RESULTING IN TIP SEPARATION. THE SEPARATED PORTION WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-PHILIPS WIRE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE TIP SEPARATION REQUIRING INTERVENTION (SNARE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438883 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING REMOVAL TO CHECK THE NORMALIZATION AFTER MEASUREMENT, IT WAS NOTED THAT THE GUIDEWIRE WAS FRAYED/DAMAGED. THE PROCEDURE WAS COMPLETED 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 21425167 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192886, K202543. One submission often covers many models, so check the product and lot details in each record.

• Z-1270-2022 · May 16, 2022 · Terminated
  Philips OmniWire Pressure guide wire REF 89185J PN 300000252891