Comet™ II H74939359110Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08714729960140), received between Sep 15, 2020 and Sep 8, 2026 — classified as 14 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Contamination; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677213 ↗
• MalfunctionAug 5, 2026Break

  FFR "[fractional flow reserve]" procedure was being performed on patient. The tip of the FFR wire broke inside the patient's coronary artery. It was retrieved with a snare; a dissection of the artery was caused, and the vessel was stented. Patient remained stable the entire procedure.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 50150415 ↗
• InjuryJul 15, 2026Fracture

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A COMET PRESSURE WIRE WAS SELECTED FOR USE. HOWEVER, WHILE INSIDE THE PATIENT, THE COMET WIRE FRACTURED. AN ATTEMPT TO SNARE WAS UNSUCCESSFUL SO A STENT WAS PLACED TO PIN THE DETACHED PIECE AGAINST THE ARTERY WALL. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 25829195 ↗
• MalfunctionMar 4, 2026Nonstandard Device; Calibration Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 17FEB2026. IT WAS REPORTED THAT THE DEVICE WOULD NOT EQUALIZE. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A COMET II GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WOULD NOT EQUALIZE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSURE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514178 ↗
• MalfunctionFeb 24, 2026Nonstandard Device; Deformation Due to Compressive Stress

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 4FEB2026. IT WAS REPORTED THAT A KINK OCCURRED. WHEN THE COMET II WIRE WAS REMOVED FROM THE HOOP, IT WAS KINKED. A NEW WIRE WAS USED AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431757 ↗
• MalfunctionFeb 11, 2026Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JAN2026. IT WAS REPORTED THERE WAS A BLANK SCREEN ONCE COMET WIRE WAS CONNECTED. AN FG COMET II WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT A BLANK SCREEN WAS OBSERVED ONCE THE COMET WAS CONNECTED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE BODY WAS DETACHED 38.2CM FROM DISTAL TO PROXIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318530 ↗
• MalfunctionJun 24, 2025Failure to Zero; Adverse Event Without Identified Device or Use Problem; Failure to Zero; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 03JUN2025. IT WAS REPORTED THAT THE DEVICE FAILED TO BE ZEROED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN FG COMET II WAS SELECTED FOR USE FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, AFTER THE COMET WIRE WAS CONNECTED IT GAVE AN ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE WIRE WAS FOUND DETACHED FROM THE SEAM WELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324291 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A FG COMET II US WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING INSERTION, IT WAS NOTED THAT THE TIP BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137048 ↗
• MalfunctionMay 22, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILE PACKAGE WAS OPEN. A FG COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE STERILE PACKAGE WAS OPEN. THE BOX ON THE OUTSIDE WAS CLOSED AND THE BLUE STICKER WAS INTACT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. NO COMPLICATIONS WERE REPORTED, AND PATIENT IS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075564 ↗
• InjuryMay 2, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A COMET II WAS SELECTED FOR USE. DURING THE PROCEDURE, A COMET WIRE WAS INSERTED FOR FRACTIONAL FLOW RESERVE (FFR) ASSESSMENT. THE PHYSICIAN NOTED THAT THE VESSEL WAS NOT DIFFICULT TO WIRE, AND NO ISSUES WERE ENCOUNTERED WITH WIRE MANIPULATION DURING INSERTION. HOWEVER, UPON COMPLETION OF THE TESTING, THE WIRE BECAME STUCK AND BROKE AT THE TIP WHILE STILL INSIDE THE PATIENT. ATTEMPTS TO RETRIEVE THE BROKEN SEGMENT WERE UNSUCCESSFUL, LEADING THE PHYSICIAN TO STENT THE VESSEL IN ORDER TO TACK THE WIRE TIP AGAINST THE VESSEL WALL. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD BY PLACING THE STENT OVER BROKEN WIRE TIP. THE PATIENT WAS STABLE POST PROCEDURE, HOWEVER, WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE WITH DISCHARGE ON AN UNKNOWN DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21955549 ↗
• InjuryApr 30, 2025Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND DISSECTION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING REMOVAL OF THE WIRE, THE WIRE TIP WAS CAUGHT AND ENTANGLED IN A PREVIOUSLY PLACED, UNDER DEPLOYED STENT IN THE DISTAL LAD ARTERY. DESPITE OF NORMAL REMOVAL TECHNIQUE, THE WIRE TIP SEPARATED FROM THE WIRE AND BECAME LODGED ON A STENT STRUT AND CAUSED A DISSECTION. THE SEPARATED TIP WAS LEFT IN THE LAD. ATTEMPTS TO DELIVER AND DEPLOY AN ADDITIONAL STENT AT THE AFFECTED SITE WERE UNSUCCESSFUL. BALLOON PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED TO COMPLETE THE PROCEDURE, AND THE PATIENT CONDITION WAS STABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 21938289 ↗
• MalfunctionApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE MANIPULATING, THE COMET GUIDEWIRE TIP BROKE OFF DUE TO GUIDE KINKING. THE ENTIRE SYSTEM WAS SAFELY REMOVED FROM THE PATIENT, AND NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED USING NEW COMET II WIRE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925522 ↗
• MalfunctionMar 12, 2025Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 18FEB2025. IT WAS REPORTED THAT THE GUIDEWIRE WAS DAMAGED. A COMET II WAS SELECTED FOR USE. DURING THE PROCEDURE, AS THE PHYSICIAN WAS ADVANCING THE WIRE INTO THE HEMOSTATIC VALVE, HE FELT THE BURR LIKE AREA ON THE WIRE AND DID NOT PROCEED WITH ADVANCING IT INTO THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE TIP WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590105 ↗
• MalfunctionMar 10, 2025Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED. A COMET II PRESSURE GUIDE WIRE WAS SELECTED FOR USE. UPON USING THE COMET II PRESSURE GUIDEWIRE, THE BLUE LINE ON THE SCREEN DROPPED OUT. THEY TURNED THE SYSTEM OFF THEN BACK ON, THEY TRIED UNPLUGGING THE WIRE THEN PLUGGING IT BACK IN THEN THEY SWITCHED OUT WIRES AND THE PROBLEM STILL EXISTED. THE PROCEDURE WAS NOT COMPLETED. DUE TO THIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562299 ↗
• MalfunctionMar 10, 2025Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELED. A COMET II PRESSURE GUIDE WIRE WAS SELECTED FOR USE. UPON USING THE COMET II PRESSURE GUIDEWIRE, THE BLUE LINE ON THE SCREEN DROPPED OUT. THEY TURNED THE SYSTEM OFF THEN BACK ON, THEY TRIED UNPLUGGING THE WIRE THEN PLUGGING IT BACK IN THEN THEY SWITCHED OUT WIRES AND THE PROBLEM STILL EXISTED. THE PROCEDURE WAS NOT COMPLETED. DUE TO THIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562298 ↗
• MalfunctionDec 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO FG COMET II US WERE SELECTED FOR USE. DURING PROCEDURE, NO READING WOULD COME UP WITH THE TWO COMET WIRES. THE PROCEDURE WAS ABORTED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893046 ↗
• MalfunctionDec 10, 2024Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO FG COMET II US WERE SELECTED FOR USE. DURING PROCEDURE, NO READING WOULD COME UP WITH THE TWO COMET WIRES. THE PROCEDURE WAS ABORTED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893013 ↗
• MalfunctionDec 9, 2024Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INTERNAL PACKAGING OF THE DEVICE WAS TORN, AND THE STERILITY OF THE DEVICE IS IN QUESTION. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885127 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE COMET WIRE WAS FRACTURED. A COMET II WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE POST-PROCEDURE IVUS RUN, THE IVUS ADVANCED OVER THE COMET WIRE TOO FAR AND THE WIRE FRACTURED AT THE TRANSDUCER OF THE WIRE. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545204 ↗
• InjuryOct 25, 2024Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH (B)(4) THAT A DEVICE FRACTURE OCCURRED AND GOT DISLODGED IN THE LESION. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A COMET II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BROKE AT THE END AND WAS DISLODGED INTO A CORONARY ARTERY. THE PATIENT REQUIRED AN ADDITIONAL CARDIAC CATHETERIZATION PROCEDURE TO REMOVE THE FRAGMENT WIRE. THE FRAGMENT OF THE GUIDEWIRE WAS REMOVED COMPLETELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534765 ↗
• MalfunctionSep 26, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT A WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE COULD NOT ADVANCE IN THE LESION, SO THE DEVICE WAS REMOVED, AND IT WAS NOTICED THAT THE 3CM RADIOPAQUE TIP WAS NO LONGER ATTACHED TO THE WIRE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE TIP WAS FOUND TRAPPED IN THE DISTAL GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311502 ↗
• MalfunctionSep 10, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A GUIDEWIRE ISSUE OCCURRED. THE COMET PRESSURE WIRE WAS SELECTED FOR USE WITH AN OPTICROSS IMAGING CATHETER. DURING THE PROCEDURE, THE PRESSURE WIRE WAS SHAVED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185201 ↗
• MalfunctionAug 8, 2024

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND FATIGUE ON EXERTION. PROCEDURE: HEART CATHETERIZATION. COMET WIRE WOULD NOT READ AN AO (AORTIC) PRESSURE. STAYED AT ZERO EVEN WHEN TRANSDUCER WAS OPEN TO THE PATIENT. STILL UNABLE TO ZERO. IVUS (INTRAVASCULAR ULTRASOUND) USED INSTEAD. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, COMET II (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Fatigue

  MAUDE report 19937557 ↗
• InjuryMay 7, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A COMET II PRESSURE GUIDEWIRE WAS ADVANCED TO THE LESION TO TAKE A DIASTOLIC HYPEREMIA-FREE RATION (DFR) MEASUREMENT. THE DFR WAS NEGATIVE, HOWEVER THE PHYSICIAN OPTED TO USE INTRAVASCULAR ULTRASOUND (IVUS) FOR FURTHER INFORMATION COLLECTION. DURING PROCEDURE, WHILE LOADING THE OPTICROSS 6 HD ON THE WIRE, THERE WAS RESISTANCE, SO THE WIRE WAS WIPED CLEAN AND THEN THE OPTICROSS TRACKED SMOOTHLY DOWN THE WIRE. A SINGLE INTRAVASCULAR ULTRASOUND (IVUS) RUN WAS SUCCESSFULLY PERFORMED USING A SLED, HOWEVER WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE OPTICROSS THERE WAS A LOT OF RESISTANCE. PHYSICIAN THEN REMOVED THE COMET WIRE AND OPTICROSS TOGETHER AS A SYSTEM, HOWEVER THE DISTAL TIP OF THE WIRE HAD SHEARED OFF AND WAS RETAINED IN THE LEFT MAIN/GUIDE CATHETER. AN ATTEMPT WAS MADE TO SNARE THE TIP OF THE WIRE, AND THIS CAUSED IT TO MIGRATE INTO THE RAMUS ARTERY WHERE IT WAS THEN STENTED INTO PLACE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262295 ↗
• InjuryApr 10, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED AT THE DISTAL RIGHT CORONARY ARTERY. A COMET II PRESSURE GUIDEWIRE WAS USED. DURING PROCEDURE, THERE WAS NO PROBLEM IN DELIVERING THE COMET II GUIDEWIRE DOWN THE DISTAL RIGHT CORONARY ARTERY. PHYSICIAN THEN ENCOUNTERED RESISTANCE FROM THE COMET II WIRE AND WOULD NOT EXIT THE VESSEL. THE COMET II WIRE WAS STUCK AT SAME POSITION IT WAS DELIVERED. THE PHYSICIAN CONTINUED TO PULL THE WIRE TO RETRIEVE IT; HOWEVER, IT COULD NOT BE REMOVED. THE COMET II GUIDEWIRE WAS PULLED WITH MORE FORCE AND THE DISTAL PART OF THE WIRE, THE "RADIOPAQUE" PORTION, BROKE OFF IN THE VESSEL. THE REMAINING PART OF THE COMET WIRE CAME OUT OF THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AND HAD BEEN SCHEDULED FOR A BY-PASS SURGERY BECAUSE OF TRIPLE VESSEL DISEASE. PATIENT UNDERWENT SUCCESSFUL CORONARY ARTERY BYPASS GRAFTING SURGERY, WITH NO COMPLICATIONS. THE DISTAL TIP PART OF THE COMET WIRE WAS SUCCESSFULLY REMOVED FROM THE RIGHT CORONARY ARTERY DURING THE BY-PASS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082761 ↗