InQwireRecalls & reported problems across all models

We found 12 models of InQwire by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2020 and Sep 17, 2026 — classified as 3 deaths, 39 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (15 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. 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

Most reported InQwire problems

InQwire models

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

• InQwire® 00884450019467

  WIRE, GUIDE, CATHETER
  1 death58 reports
• InQwire® 00884450005156

  WIRE, GUIDE, CATHETER
  6 reports
• InQwire® 00884450011133

  WIRE, GUIDE, CATHETER
  5 reports
• InQwire® 00884450023563

  WIRE, GUIDE, CATHETER
  4 reports
• InQwire® 00884450021576

  WIRE, GUIDE, CATHETER
  2 reports
• InQwire® 00884450029909

  WIRE, GUIDE, CATHETER
  2 reports
• InQwire® 00884450198827

  WIRE, GUIDE, CATHETER
  1 death2 reports
• InQwire® 00884450018354

  WIRE, GUIDE, CATHETER
  1 report
• InQwire® 00884450046227

  WIRE, GUIDE, CATHETER
  1 report
• InQwire® 00884450056295

  WIRE, GUIDE, CATHETER
  1 death1 report
• InQwire® 00884450196373

  WIRE, GUIDE, CATHETER
  1 report
• InQwire® 00884450196380

  WIRE, GUIDE, CATHETER
  1 report

Recent InQwire adverse event reports

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

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Customer reports during a procedure to treat atrial fibrillation an InQwire Guidewire was used. A pericardial effusion was noted after the Volt PFA Catheter was introduced into the left atrium. One ablation (in LSPV) was attempted and canceled due to a continued drop in left atrial pressure, at which time a pericardial effusion was identified via ViewFlex ICE catheter. A pericardiocentesis was performed, and the case was subsequently aborted. At the time of the event, the Volt catheter, non-Abbott device (Merit InQwire guidewire), and 13 Fr Agilis sheath were present in the patient. The exact source of the perforation remains unknown, though the Merit InQwire nor the transseptal puncture which was performed using non-Abbott device (Versacross by Boston Scientific) could not be excluded as a potential contributing factors. The patient is hemodynamically stable and currently recovering appropriately. There were no performance issues with any device.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 50800776 ↗
• 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 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  A CUSTOMER ALLEGED DURING A PROCEDURE, THE PHYSICIAN FOUND THE TIP OF THE GUIDE WIRE WAS KINKED. IT WAS REPLACED WITH A NEW ONE TO COMPLETE PROCEDURE. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550717 ↗
• 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 ↗
• DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A FARAVIEW PROCEDURE WAS PERFORMED WITHOUT IMAGING GUIDANCE. DURING THE PROCEDURE, NO DEVICE MALFUNCTION OR SPECIFIC INTRA-PROCEDURAL ISSUES WERE REPORTED; HOWEVER, DIFFICULTY ACCESSING THE LEFT VEINS WAS NOTED, REQUIRING MULTIPLE GUIDEWIRE INSERTION ATTEMPTS. NO ABNORMALITIES WERE IDENTIFIED ON ECHOCARDIOGRAPHY AT THE CONCLUSION OF THE PROCEDURE. SEVERAL HOURS POST-PROCEDURE, THE PATIENT DEVELOPED CLINICAL DETERIORATION, AND ECHOCARDIOGRAPHY IDENTIFIED CARDIAC TAMPONADE WITH PERICARDIAL EFFUSION. A THORACIC DRAIN WAS PLACED, RESULTING IN TEMPORARY CLINICAL IMPROVEMENT. LATER THAT NIGHT, THE PATIENT EXPERIENCED RECURRENT TAMPONADE REQUIRING EMERGENT OPEN-CHEST SURGICAL INTERVENTION. INTRAOPERATIVE FINDINGS IDENTIFIED DAMAGED TISSUE BENEATH THE LEFT PULMONARY VEINS, SUSPECTED TO BE THE SOURCE OF PERICARDIAL EFFUSION AND TAMPONADE. NO DISCRETE PERFORATION OR DEFECT OF A SPECIFIC DEVICE WAS IDENTIFIED. THE TAMPONADE WAS ASSESSED AS PROCEDURE-RELATED; HOWEVER, A DIRECT CAUSAL ASSOCIATION TO A SPECIFIC MEDICAL DEVICE COULD NOT BE ESTABLISHED. THE PATIENT REQUIRED HOSPITALIZATION BEYOND STANDARD POST-PROCEDURE CARE AND ULTIMATELY DIED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24199370 ↗
• 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 ↗

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
• Monarch6 models · 37 reports · 7 recalls
• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls