InQwire® 00884450019467Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00884450019467), received between May 14, 2024 and Sep 9, 2026 — classified as 1 death, 27 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Insufficient Device Problem Information

  Patient problems: Pericardial Effusion

  MAUDE report 50701998 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A customer alleged after a procedure in the electrophysiology lab, a pericardial effusion was noted on Intracardiac echocardiography (ICE). A peri-centesis procedure produced 150cc of fluid. An echo the next day confirmed the patient was ok and he was released.

  Patient problems: Pericardial Effusion

  MAUDE report 50235134 ↗
• DeathJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PFA PROCEDURE, AFTER PERFORMING THE TRANSSEPTAL PUNCTURE USING AN NRG RADIOFREQUENCY NEEDLE, AN EXCHANGE OVER A GUIDEWIRE WAS CARRIED OUT WITH A NON-MERIT FARADRIVE SHEATH, AND A NON-MERIT FARAWAVE CATHETER WAS INSERTED ACCORDING TO INSTRUCTIONS. ONCE THE LEFT ATRIAL MAPPING WAS COMPLETED, PFA EROGATIONS WERE PERFORMED IN THE PULMONARY VEINS AND ON THE POSTERIOR WALL. A DROP IN BLOOD PRESSURE AND CYANOSIS OF THE PATIENT'S FACE WERE OBSERVED DURING PROCEDURE. CARDIAC TAMPONADE WAS SUSPECTED DUE TO THE PRESENCE OF PERICARDIAL EFFUSION CONFIRMED BY ECHOCARDIOGRAPHY. RESUSCITATION PROCEDURES AND PERICARDIOCENTESIS WERE PERFORMED. THE PATIENT SUBSEQUENTLY EXPERIENCED MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION/ELECTROMECHANICAL DISSOCIATION. THE ENERGY DELIVERIES BY THE NON-MERIT FARAWAVE NAV CATHETER NEVER RECORDED ERRORS 301 OR 303 AND DEVICES FLUSHING PROCEDURES WERE CARRIED OUT CORRECTLY. THE PHYSICIAN CONSIDERED THE COMPLICATIONS AND SUBSEQUENT PATIENT DEATH TO BE CAUSED OR CONTRIBUTED TO BY THE PROCEDURE ITSELF AND NOT THE DEVICE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Ventricular Fibrillation

  MAUDE report 25552866 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS THAT THE PATIENT HAD A PERICARDIAL EFFUSION. THEY WENT TRANSSEPTAL TO THE LEFT AND MAPPED, AND FOR A BRIEF TIME THEY WERE UNABLE TO SEE THE HEART SPAN WIRE, BUT EVENTUALLY FOUND IT SHORTLY AFTER. THEY ADDED THAT AFTER THIS POINT THEY WERE GETTING INCONSISTENT BLOOD PRESSURE READINGS, AND THE ONE DOCUMENTED AFTER GOING TRANSSEPTAL WAS LOWER THAN THEIR INITIAL READING, AND WERE WORKING ON GETTING IT BACK TO CONSISTENT. THEY THEN WENT TO THE RIGHT SIDE TO MAP IN THE RV, AND WHEN THEY STARTED ABLATING, THEY WERE UNABLE TO REACH WHERE THEY NEEDED TO GO. THEY PUT THE CATHETER BACK INTO THE BODY AND AT THIS POINT NOTICED THE EFFUSION. THEY STATED THAT THEY ORDERED A STAT ECHO, AND THEY CONFIRMED THE EFFUSION EXTERNALLY ON ULTRASOUND. THEY STATED THAT THEY WERE STILL NOT GETTING CONSISTENT BLOOD PRESSURE READINGS. THEY TOOK AN ARTERIAL PRESSURE, AND THIS CAME BACK AS LOW. THEY STATED THAT AN INTERVENTIONALIST PERFORMED A PERICARDIOCENTESIS AND DRAINED 200CC'S. THEY ADDED THAT THE BLOOD PRESSURE CAME BACK UP AND THE PATIENT IS CURRENTLY STABLE. THE PHYSICIAN BELIEVES THE ISSUE WAS WHEN THEY WERE GOING TRANSSEPTAL, THE NEEDLE MAY HAVE POSSIBLY PUNCTURED THE RA WHEN THEY COUL

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25243524 ↗
• MalfunctionMar 13, 2026Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking

  THE ACCOUNT ALLEGES THAT DURING VEIN VERIFICATION, THE GUIDEWIRE BECAME STUCK AND IT WAS IMPOSSIBLE TO MOVE IT FORWARD OR BACKWARD. AFTER SEVERAL ATTEMPTS, THE CATHETER AND GUIDEWIRE WERE REMOVED. EVEN WHEN TRYING TO REMOVE IT BY PULLING HARD, THE PROVIDER WAS UNABLE TO REMOVE IT. THE GUIDE BROKE IN THE CATHETER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591945 ↗
• MalfunctionFeb 25, 2026Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, AFTER ISOLATING THE TWO LEFT VEINS, THE GUIDEWIRE BECAME STUCK AND DIFFICULT TO MANEUVER. AFTER SEVERAL ATTEMPTS TO REATTACH THE LEAD, THE PROVIDER WAS SUCCESSFUL; HOWEVER, THE WIRE BROKE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447369 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER ALLEGED NOTHING UNUSUAL WAS NOTED THROUGHOUT THE CASE. PHYSICIAN WAS TRYING TO WIRE THE LEFT INFERIOR PHRENIC VEIN (LIPV) BUT HAD GONE MORE ANTERIORLY WITH THE WIRE AND HE BELIEVES THAT WAS WHAT HAD CAUSED THE PERFORATION. SECOND ATTEMPT AT WIRING THE LIPV WAS SUCCESSFUL. PATIENT WAS HAEMODYNAMICALLY STABLE THROUGHOUT PROCEDURE. HOWEVER, PATIENT WAS HYPOTENSIVE AFTER ANAESTHETIC HAS WORN OFF ABOUT AN HOUR LATER AFTER THE PROCEDURE. PATIENT BLOOD PRESSURE CONTINUED TO WORSEN 3 HOURS LATER AND AN ECHO WAS ORDERED WHICH 1-1.5 CM OF PERICARDIAL EFFUSION WAS FOUND. PHYSICIAN DID PERICARDIOCENTESIS AND PATIENT BLOOD PRESSURE AND HEART RATE RETURN TO NORMAL AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24367063 ↗
• MalfunctionFeb 11, 2026Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking

  CUSTOMER ALLEGED THE STEEL WIRE OF THE CATHETER COULD NOT BE RETRACTED. THE CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT TOGETHER. THE GUIDEWIRE LUMEN WAS STILL INTACT AND CHANGING THE DEPLOYMENT STATE OF THE CATHETER DID NOT RESOLVE THE GUIDEWIRE STUCK ISSUE. EVENTUALLY, OUTSIDE OF THE PATIENT AND USING GREAT FORCE, THE GUIDEWIRE WAS REMOVED FROM THE CATHETER. THE GUIDEWIRE WAS DISCARDED AND WILL NOT BE RETURNED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. NO PATIENT COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312514 ↗
• MalfunctionJan 28, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES DURING A PROCEDURE THE WIRE WAS STUCK AT THE CATHETER TIP AFTER BEING PULLED BACK INTO THE RIGHT ATRIUM FROM THE LEFT. THE PHYSICIAN WAS UNABLE TO ADVANCE OR WITHDRAW THE WIRE. UPON CLOSE EXAMINATION, IT SEEMS THERE WAS A PIECE OF FIBER/PLASTIC THAT HAD PEELED OFF. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199298 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES THERE WAS TISSUE ENTRAPMENT BETWEEN THE TIP OF THE CATHETER AND THE CATHETER. THE PHYSICIAN RETRACTED THE GUIDEWIRE BUT THERE WAS RESISTANCE, ONCE THE CATHETER WAS REMOVED FROM THE BODY, THERE WAS FIBROUS TISSUE IN BETWEEN THE WIRE AND THE TIP OF THE CATHETER. AFTERWARDS THE TISSUE WAS REMOVED WITH SURGICAL EQUIPMENT FROM THE GUIDEWIRE BUT THE GUIDEWIRE WAS STILL STUCK INSIDE THE LUMEN OF THE CATHETER. RESULTING IN REMOVAL OF THE GUIDEWIRE FROM THE FRONT END OF CATHETER. A NEW GUIDEWIRE WAS USED FOR THE REMAINDER OF THE CASE. THE ABLATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119435 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES THAT AFTER THE GUIDEWIRE WAS INSERTED INTO THE CATHETER, IT COULD NOT BE ADVANCED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119432 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES THAT DURING CATHETER PREPARATION, THE WIRE COULD NOT BE ADVANCED. THE WIRE WAS DIFFICULT TO REMOVE FROM THE CATHETER. THE CATHETER WAS THEN REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119217 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES THAT AFTER ABLATION OF THREE VEINS, THE GUIDEWIRE BECAME STUCK. IT COULD NOT BE ADVANCED NOR REMOVED. THE CATHETER WAS REMOVED WITH THE GUIDEWIRE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119216 ↗
• MalfunctionJan 20, 2026Difficult to Remove; Difficult to Advance

  THE ACCOUNT ALLEGES THAT DURING INSERTION, THE WIRE COULD NOT BE ADVANCED. THE WIRE WAS DIFFICULT TO REMOVE FROM THE CATHETER. THE CATHETER WAS THEN REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119212 ↗
• MalfunctionJan 6, 2026Difficult to Advance

  THE ACCOUNT ALLEGES THAT WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE IN THE LEFT ATRIUM WITH A PFA CATHETER IT WAS UNABLE TO ADVANCE OR RETRACT. THE CATHETER AND WIRE WERE BOTH REMOVED SIMULTANEOUSLY. DAMAGE WAS SUSTAINED TO THE CATHETER DURING THE REMOVAL. A NEW PFA CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980238 ↗
• MalfunctionJan 6, 2026Difficult to Advance

  THE ACCOUNT ALLEGES DURING USE THE PHYSICIAN NOTICED THAT THE WIRE WAS NOT ABLE TO MOVE AND BECAME STUCK. DURING THE PREPARATION OF THE CATHETER AND THE SUCCESSFUL ABLATION OF THE LEFT SUPERIOR PULMONARY VEIN THE CATHETER AND THE WIRE SHOWED NO ANOMALIES. THE PHYSICIAN DECIDED TO CHANGE THE CATHETER TO FINISH THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980236 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER ALLEGED A CARDIAC TAMPONADE HAPPENED DURING AN ATRIAL FLUTTER ABLATION (FARAPULSE PROCEDURE) IN WHICH A MERIT GUIDEWIRE WAS USED, THEY PERFORMED ADDITIONAL SURGERY AND DISCOVERED THAT THE ORIGIN WAS FROM THE APPENDAGE. PATIENT ADMITTED TO HOSPITAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 23815589 ↗
• MalfunctionDec 16, 2025Difficult to Advance; Difficult to Advance

  A CUSTOMER ALLEGED A MERIT GUIDEWIRE WAS USED DURING THE PREPARATION OF THE FARAWAVE, IT WAS NOTICED THAT THE GUIDEWIRE CANNOT BE ADVANCED AND GETS STUCK. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815397 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT THE FARAWAVE CATHETER WAS PREPARED PER IFU AND USED FOR ABLATION IN THE LEFT UPPER PULMONARY VEIN WITHOUT ISSUE. WHEN REPOSITIONING TO THE LEFT LOWER PULMONARY VEIN USING A GUIDEWIRE, THE PHYSICIAN REPORTED THE WIRE BECAME STUCK AND COULD NOT BE ADVANCED INDEPENDENTLY. THE CATHETER AND WIRE WERE REMOVED TOGETHER. UPON REMOVAL, THE WIRE WAS FOUND TO HAVE A PARTIAL OUTER-COIL FRACTURE BUT REMAINED INTACT. THE CATHETER FUNCTIONED NORMALLY OUTSIDE THE BODY. BOTH DEVICES WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780671 ↗
• MalfunctionDec 9, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PVI PROCEDURE, THE WIRE BECAME DIFFICULT TO MANEUVER WHEN IN THE LEFT VEINS. AS THE WIRE WAS BEING REMOVED, IT BROKE. AN ATTEMPT WAS MADE TO ADVANCE THE WIRE AND IT WAS NOT ABLE TO. WITH EXCESSIVE FORCE, THE WIRE WAS PULLED BACK AND BROKE. A SECOND WIRE AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760521 ↗
• MalfunctionDec 9, 2025Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking; Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking

  CUSTOMER ALLEGED ANOTHER MANUFACTURE CATHETER WAS PREPARED ACCORDING TO ALL RECOMMENDATIONS, AFTER ABLATION OF THE LEFT SUPERIOR PULMONARY VEIN (LSPV) THE PHYSICIAN WAS UNABLE TO PUSH OR PULL THE MERIT GUIDEWIRE. IT WAS COMPLETELY STUCK IN THE CATHETER. THEY REMOVED THE CATHETER AND NOTE THE GUIDEWIRE WAS DAMAGED. A DIFFERENT GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758887 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THAT THE ELECTRODE/GUIDEWIRE BECAME STUCK INSIDE THE DEVICE. COMPETITOR CATHETER WAS REPLACED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692645 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER THE PROCEDURE A PERICARDIAL EFFUSION OCCURRED, WHICH WAS PROMPTLY DRAINED. THE PHYSICIAN BELIEVES THAT THE CORONARY SINUS GOT PERFORATED BY THE CS CATHETER BUT ALSO STATED THAT THE COMPLICATION IS NOT A PRODUCT RELATED ISSUE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER SURGICAL PROCEDURES.

  Patient problems: Pericardial Effusion

  MAUDE report 23692644 ↗
• MalfunctionNov 26, 2025Difficult to Advance; Difficult to Advance

  BOSTON SCIENTIFIC FORWARDED A REPORT FROM A CUSTOMER ALLEGING A PROBLEM ADVANCING THE GUIDEWIRE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659574 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING USE WHILE ATTEMPTING TO ACCESS THE RIGHT INFERIOR PULMONARY VEIN THE PROVIDER SPENT A LONG TIME PUSHING AND PULLING THE GUIDEWIRE MULTIPLE TIMES. THEY DIDN'T FIND IT, SO THEY STOPPED THE PROCEDURES, BUT AFTER, THERE WAS A FALL OF BLOOD PRESSURE, AND THEY FOUND OUT THAT THERE WAS A CARDIAC TAMPONADE. SO, THEY STARTED THE PERICARDIAL DRAINING.

  Patient problems: Cardiac Tamponade

  MAUDE report 23658158 ↗