HeartSpanRecalls & reported problems across all models

We found 5 models of HeartSpan by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2021 and Nov 25, 2025 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 FDA recall records name at least one of these models by its device identifier.

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

HeartSpan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 19, 2021Class IITerminated

   The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.

   Z-1263-2021 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 19, 2021Class IITerminated

   The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.

   Z-1262-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported HeartSpan problems

HeartSpan models

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

• HeartSpan® 00884450489345

  Trocar
  1 recall1 death2 reports
• HeartSpan® 00884450489369

  Trocar
  1 recall0 reports
• HeartSpan® 00884450489437

  Trocar
  5 reports
• HeartSpan® 00884450630754

  Trocar
  2 reports
• HeartSpan® 00884450693704

  Introducer, catheter
  1 report

Recent HeartSpan adverse event reports

The 10 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI), A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE DIAGNOSTIC CATHETERS WERE PLACED IN THE BUNDLE OF HIS AND RIGHT ATRIUM CORONARY SINUS POSITION AND TRANSSEPTAL PUNCTURE WAS DONE SUCCESSFULLY. AFTERWARDS THE MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT. A CARDIAC ULTRASOUND SHOWED A PERICARDIAL EFFUSION IN THE PATIENT. A PERICARDIOCENTESIS WAS THEN PERFORMED. DURING THE NEXT HOUR APPROXIMATELY 1.5 LITERS BLOOD WERE WITHDRAWN FROM THE PERICARDIUM. THE EMERGENCY TEAM ENTERED THE ROOM AND SOON THE PATIENT SHOWED ASYSTOLE. THE EMERGENCY TEAM BEGAN WITH CPR, HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED IN THE CATH LAB. THE PHYSICIAN STATED THAT THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS USED IN THIS CASE. ACCORDING TO THE PHYSICIAN THE CAUSE OF THE EFFUSION AND OF THE PATIENT'S DEATH ARE NOT CLEARLY KNOWN BUT THAT THE PERFORATION COULD HAVE POTENTIALLY OCCURRED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT ATRIUM ROOF.

  Patient problems: Asystole; Cardiac Arrest; Cardiac Perforation; Pericardial Effusion

  MAUDE report 23645273 ↗
• InjuryFeb 4, 2025Use of Device Problem; Use of Device Problem

  THE ACCOUNT ALLEGES THAT DURING A STRUCTURAL HEART INTERVENTION [LAA] PROCEDURE, VESSEL TRAUMA OCCURRED. THE ACCOUNT BELIEVES THIS WAS DUE TO USE ERROR. THE OPERATOR HAD APPLIED TOO MUCH PRESSURE DURING THE PUNCTURE [TENTING] ULTIMATELY BREAKING THROUGH THE SEPTAL WALL WITH THE ACCESS SHEATH RESULTING IN DAMAGE TO THE ATRIAL ROOF. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Perforation

  MAUDE report 21304805 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST TRANSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION [PVI] PROCEDURE, A TRANSESOPHAGEAL ECHO [TEE] WAS ORDERED TO DETERMINE THE CAUSE OF BLOOD PRESSURE CHANGES IN THE PATIENT. THE TEE ACCURATELY IDENTIFIED 13MM PERICARDIAL EFFUSION/FLUID COLLECTING WITHIN THE PATIENT'S PERICARDIAL SAC. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO PREVENT CARDIAC TAMPONADE FOR THIS PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944178 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST TRANSEPTAL PUNCTURE FOR A PULMONARY VEIN ISOLATION [PVI] PROCEDURE, A TRANSESOPHAGEAL ECHO [TEE] WAS ORDERED TO DETERMINE THE CAUSE OF BLOOD PRESSURE CHANGES IN THE PATIENT. THE TEE ACCURATELY IDENTIFIED PERICARDIAL EFFUSION/FLUID COLLECTING WITHIN THE PATIENT'S PERICARDIAL SAC. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO PREVENT CARDIAC TAMPONADE FOR THIS PATIENT. THE BLEEDING COULD NOT BE STOPPED IN THE FURTHER COURSE OF THE PROCEDURE. SURGERY WAS REQUIRED. NO ADDITIONAL PATIENT COMPLICATIONS TO REPORT. THE DEVICE WAS DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19943337 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER A TRANSEPTAL PUNCTURE TECHNIQUE DURING AN A-FIB ABLATION PROCEDURE, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH POOR HEMODYNAMIC PRESSURE. A PERICARDIOCENTESIS WAS SUCCESSFULLY PERFORMED TO DRAIN THE FLUID. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE EFFUSION FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842869 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST-PVI ABLATION PROCEDURE THE PATIENT SUFFERED A CARDIAC TAMPONADE EVENT. THERE WERE NO SIGNS OF EFFUSION OR INJURY DURING THE ACTUAL PROCEDURE. THE PHYSICIAN STATES THAT THE PERFORATION LIKELY OCCURRED DURING THE SECOND TRANSEPTAL PUNCTURE ATTEMPT DUE TO THE ANGLE OF THE TARGETED SEPTUM. THE PATIENT'S HEART RATE DID INCREASE DURING THE ABLATION PROCEDURE WHICH WAS SUCCESSFULLY MANAGED BY THE ATTENDING ANESTHESIOLOGIST. THE PATIENT ALSO REQUIRED A BLOOD TRANSFUSION POST-PROCEDURE AND BECAME STABLE AFTER THE NECESSARY INTERVENTIONAL TREATMENTS. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552410 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING THE ABLATION PHASE OF A PROCEDURE, THE PATIENT DEVELOPED ATRIAL TACHYCARDIA AND HYPOTENSION. AN ECHOCARDIOGRAM WAS PERFORMED AND FOUND THE MYOCARDIAL TISSUE HAD BEEN PERFORATED AND PERICARDIAL EFFUSION. THE PERFORATION WAS SEALED AND THE PROCEDURE CONTINUED. ANOTHER EFFUSION DEVELOPED AND THE PROCEDURE DISCONTINUED. ONLY THE LEFT PULMONARY VEINS WERE ISOLATED DURING THE PROCEDURE. THE PATIENT HAS NOT SUFFERED CONSEQUENCES DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675234 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE ACCOUNT ALLEGES THAT DURING AN A-FIB PROCEDURE, WHILE UNDER GENERAL ANESTHESIA, DURING THE MAPPING PHASE, THE ANESTHESIOLOGISTS NOTICED A DEPRECIATION OF THE VITAL PARAMETERS, SUCH AS BLOOD PRESSURE DROP. THE TRANSESOPHAGEAL ECHO SHOWED FLUID IN THE PERICARDIUM, THUS A PERICARDIOCENTESIS WAS PERFORMED FOR DRAINING THE BLOOD. AS THE FLUID DRAINED, IT WAS CONCLUDED THAT OPEN CHEST SURGERY WAS NEEDED FOR THE BLEEDING TO BE STOPPED. THE PATIENT WAS TRANSFERRED TO THE OR AND THE SURGEONS FOUND A PERFORATION IN THE LEFT ATRIAL APPENDAGE (LAA). THE PATIENT WAS TRANSFERRED TO THE ICU POST-OP. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 13656743 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST PULMONARY VEIN ISOLATION THE PATIENT WAS HYPOTENSIVE. APPROXIMATELY ONE HOUR POST PROCEDURE THE PATIENT CONTINUED TO BE HYPOTENSIVE AND APPEARED TO BE IN TAMPONADE. THE TRANSSEPTAL PUNCTURE WAS DIFFICULT, PERFORMED WITH TEE. NO ABLATION WAS MADE ON THE LEFT POSTERIOR WALL.

  Patient problems: Cardiac Tamponade

  MAUDE report 12700211 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED. IT IS THOUGHT THAT THE HEARTSPAN TRANSSEPTAL NEEDLE EITHER "NICKED" THE AORTA OR THE ROOF OF THE LEFT ATRIUM. AFTER ISOLATING THREE OF THE PULMONARY VEINS, THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE AND ECHO. MEDICAL INTERVENTION WAS A PERICARDIOCENTESIS PROCEDURE WITH 1.5 L OF FLUID BEING REMOVED. "KCENTRA" PROTHROMBIN WAS INJECTED THROUGH THE CENTRAL IV LINE AND "FLOSEAL" THROMBIN GEL FOAM WAS ALSO INJECTED INTO THE PATIENT'S PERICARDIAL SAC. AFTER ABOUT 30 MINUTES, ANOTHER TRANSTHORACIC ECHO WAS PERFORMED FOR CONFIRMATION AND THE PATIENT WAS THEN TAKEN INTO ICU FOR FURTHER MONITORING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO FURTHER PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Cardiac Tamponade

  MAUDE report 12239771 ↗

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