OmniWire Pressure guide wire 89185JRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00845225003050), received between Jun 9, 2021 and Sep 17, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (11 reports).

2 FDA recall records name this device's 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, 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 ↗

2. May 16, 2022Terminated

   Due to a potential failed sterilization process.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50805915 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE IN A MODERATELY CALCIFIED MID LAD. AFTER ADVANCING THE WIRE A FEW CENTIMETERS THROUGH A NON-PHILIPS GUIDE CATHETER, AN ERROR MESSAGE APPEARED. DURING PULLBACK FROM THE GUIDE CATHETER, THE WIRE SEPARATED APPROX. 42 CM FROM THE DISTAL TIP. THE SEPARATED PORTION AND THE GUIDE CATHETER WERE REMOVED AS A SYSTEM. THE PROCEDURE WAS POSTPONED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE OMNIWIRE SEPARATED, WAS REMOVED AS A SYSTEM, AND RESULTED IN DELAY OF THE PROCEDURE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714199 ↗
• MalfunctionDec 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN AN EMERGENT CORONARY DIAGNOSTIC PROCEDURE. DURING USE, THE WIRE FAILED TO PRODUCE A YELLOW WAVEFORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE, 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 20896934 ↗
• MalfunctionDec 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN AN EMERGENT CORONARY DIAGNOSTIC PROCEDURE. DURING USE, THE WIRE FAILED TO PRODUCE A YELLOW WAVEFORM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE, 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 20896279 ↗
• MalfunctionNov 22, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A PATIENT. DURING USE, THE WIRE COULD NOT BE NORMALIZED. 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 20764364 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING MEASUREMENT, DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634457 ↗
• MalfunctionNov 1, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING USE, MEASUREMENT DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591985 ↗
• MalfunctionOct 15, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A OMNIWIRE PRESSURE GUIDEWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING USE, MEASUREMENT DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458229 ↗
• MalfunctionOct 10, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A OMNIWIRE PRESSURE GUIDEWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING USE, MEASUREMENT DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20424104 ↗
• MalfunctionSep 25, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING USE, NORMALIZATION WAS ATTEMPTED, BUT UNSUCCESSFUL. 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 20306688 ↗
• MalfunctionNov 7, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. POST NORMALIZATION, THE WIRE WAS UNABLE TO ADVANCE; THEREFORE, IT WAS REMOVED FROM THE PATIENT TO CHANGE THE SHAPE. UPON REMOVAL, APPROXIMATELY 6-7 CM OF THE DISTAL PORTION OF THE WIRE WAS STRETCHED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, THE CORE WIRE WAS EXPOSED RESULTING IN 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 18084575 ↗
• MalfunctionOct 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A CORONARY DIAGNOSTIC PROCEDURE. DURING USE, ERROR 107 WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION, SMALL PORTIONS OF PTFE AND POLYAMIDE COATING MATERIAL WERE MISSING. IT IS UNKNOWN IF THE MISSING MATERIAL OCCURRED DURING USE IN PATIENT OR DURING TRANSIT FOR RETURN TO THE MANUFACTURER. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION DUE TO THE MISSING MATERIAL. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865714 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE OMNIWIRE SIGNAL DISAPPEARED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE RETURNED PRODUCT EVALUATION USING A MICROSCOPE, A SMALL PORTION OF THE PRESSURE SENSOR WAS BROKEN BUT REMAINED INTACT TO THE DEVICE. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION DUE TO THE FRACTURED SENSOR. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456538 ↗
• MalfunctionDec 8, 2022Detachment of Device or Device Component; Improper Flow or Infusion

  INNER LUMEN OF THE OMNIWIRE PRESSURE GUIDE WIRE THAT CONTAINS THE FRACTIONAL FLOW RESERVE TRANSDUCER DISENGAGED FROM THE OUTER WIRE LUMEN. THIS DISENGAGEMENT CAUSED A THREADING EFFECT THAT CAUSED ACUTE FLOW DISRUPTION THAT RESULTED IN FURTHER INTERVENTION TO CORRECT.

  Patient problems: Insufficient Information

  MAUDE report 15939802 ↗
• InjuryJun 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE IN THE PROXIMAL LAD, THE OMNIWIRE FRACTURED IN THE PATIENT. A SNARE WAS USED, BUT AFTER HOURS OF TRYING TO REMOVE UNSUCCESSFULLY, THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY FOR SURGICAL REMOVAL CONSIDERATION. THE PORTION OF THE OMNIWIRE (33 CM) WAS REMOVED DURING BY-PASS. THE PATIENT'S CONDITION IS UNKNOWN. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE WIRE SEPARATION REQUIRING SURGICAL INTERVENTION FOR REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 14762726 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER''S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491336 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER'S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491049 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER''S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491042 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER''S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490985 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER'S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490621 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER''S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490482 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER'S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490449 ↗
• MalfunctionMay 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  A NON-STERILE DEVICE WAS INADVERTENTLY SHIPPED TO THE CUSTOMER. THIS DEVICE WAS NOT USED IN THE PATIENT AND WAS REMOVED FROM THE CUSTOMER'S INVENTORY PER 2022R03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490408 ↗