Micra™ Introducer MI2355ARecalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00643169359888), received between Oct 10, 2014 and Sep 25, 2026 — classified as 31 deaths, 41 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (58 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 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Use of Device Problem; Human-Device Interface Problem

  It was reported that during implant the leadless Implantable Pulse Generator (IPG) dislodged after the tether was cut and was sat in mid right atrium at the tip of the delivery catheter. The device then became free of the tether and moved and was then observed in the Right pulmonary artery (RPA). The delivery system was removed and attempted retrieval using large curve agilis catheter, gooseneck snare and deflectable diagnostic catheter, then AL1 with wire to guide to the RPA branch. They were unable to get to the branch with the device with the wire, and on contrast injection no contrast reached the branch with the device in. Suspected dissection of RPA branch on fluoroscopy with small lacerations in the right upper RPA. The device embolized in RPA branch and the patient had occasional coughing and mild chest discomfort. It was also noted that the introducer was used more than six months after the use by date. The patient will be monitored with the device remaining in the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Laceration(s); No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 50895165 ↗
• MalfunctionSep 24, 2026Break

  It was reported that the valve of the introducer was damaged and unable to close. The Introducer was not used. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881727 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING IMPLANT A LARGE AMOUNT OF THROMBUS WAS ADHERED TO THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) RESULTING IN A HIGH THRESHOLDS. A LARGE AMOUNT OF THROMBUS WAS OBSERVED. ALTHOUGH THE THROMBUS AT THE TIP OF THE LEADLESS IPG COULD BE REMOVED, THE INTERNAL THROMBUS COULD NOT BE COMPLETELY REMOVED, AND CONTRAST COULD NOT BE DELIVERED AND FLUSHING COULD NOT BE PERFORMED. THE LEADLESS IPG WAS NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25591206 ↗
• DeathJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED A CARDIAC PERFORATION RESULTING IN PERICARDIAL EFFUSION. DEVICE PLACEMENT WAS TECHNICALLY CHALLENGING DUE TO A SMALL RIGHT VENTRICLE AND POSSIBLE CARDIAC ROTATION. INITIAL POSITIONING ATTEMPTS APPEARED APICAL ON FLUOROSCOPIC IMAGING IN BOTH LAO AND RAO PROJECTIONS FOLLOWING CONTRAST INJECTIONS. THE TIMING AND LOCATION OF A POTENTIAL CARDIAC PERFORATION COULD NOT BE DEFINITIVELY DETERMINED. DURING THE PROCEDURE, CONTRAST EXTRAVASATION WAS OBSERVED OUTSIDE THE CARDIAC SILHOUETTE, CONSISTENT WITH ACCUMULATION WITHIN THE PERICARDIAL SPACE. THE PATIENT PASSED AWAY.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25560688 ↗
• MalfunctionMay 7, 2026Leak/Splash; Mechanical Problem

  IT WAS REPORTED DURING IMPLANT THAT THE INTRODUCER EXHIBITED VALVE LEAKAGE AND UNABLE TO OPEN. THE INTRODUCER WAS ATTEMPTED BUT NOT USED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113185 ↗
• MalfunctionMay 5, 2026Mechanical Problem

  IT WAS REPORTED DURING IMPLANT OF LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) THAT THE MICRA INTRODUCER EXHIBITED DAMAGED VALVE AND WAS UNABLE TO CLOSE. THE INTRODUCER WAS ATTEMPTED BUT NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081993 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), IT WAS NOTED THAT THE INTRODUCER SHEATH VALVE WAS ALLOWING AIR TO BE INTRODUCED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999611 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), IT WAS NOTED THAT THE INTRODUCER SHEATH VALVE WAS ALLOWING AIR TO BE INTRODUCED. THE INTRODUCER WAS NOTED USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997112 ↗
• MalfunctionApr 23, 2026Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT AFTER THE INTRODUCER WAS INSERTED, THE VALVE EXHIBITED LEAKAGE. THERE WAS BLOOD SOAKED INTO THE TOWELS AROUND THE INSERTION SITE (PHYSICIAN ESTIMATED 20ML). THE USE OF THE INTRODUCER WAS CONTINUED AND THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24965656 ↗
• MalfunctionApr 16, 2026Leak/Splash

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE INTRODUCER VALVE WAS NOTED TO BE LEAKING AND AIR INGRESS INTO THE SHEATH WAS OBSERVED. THEREFORE, THE INTRODUCER WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895144 ↗
• DeathApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED R WAVE UNDERSENSING. THE DEVICE WAS RECAPTURED AND A NEW POSITION WAS TRIED BUT THE DEVICE EXHIBITED HIGH THRESHOLDS AND IMPEDANCES. SIMILAR RESULTS WERE SEEN AFTER A THIRD DEPLOYMENT AND A CLOT WAS CONFIRMED ON THE DEVICE AFTER IT WAS REMOVED. A NEW DEVICE WAS ASKED FOR BUT BEFORE IT COULD BE DEPLOYED THE PATIENTS BLOOD PRESSURE DROPPED AND AN ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION. CARDIAC PERFORATION AND TAMPONADE WERE ALSO NOTED. PERICARDIOCENTESIS WAS PERFORMED, HOWEVER THE BLEEDING JUST WOULD NOT STOP. AFTER THIRTY FIVE TO FORTY FIVE MINUTES OF CARDIO-PULMONARY RESUSCITATION AND TRANSFUSION THEY WERE UNABLE TO STOP THE BLEEDING AND THE PATIENT EXPIRED ON THE TABLE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24843920 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SHEATH WAS NOT AIR TIGHT DURING THE IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800144 ↗
• MalfunctionMar 11, 2026Leak/Splash; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE INTRODUCER EXHIBITED A DAMAGED HEMOSTASIS VALVE AND COULD NOT ASPIRATE OR FLUSH. NORMAL TROUBLESHOOTING OCCURRED INCLUDING TRYING TO RESET THE VALVE WITH THE DILATOR TWICE. THE PHYSICIAN ENDED UP HAVING TO TAKE A SYRINGE WITH SALINE AND PLACE IN THE VALVE TO CLOSE IT OFF TO BE ABLE TO ASPIRATE. THE PROCEDURE WAS THEN COMPLETE WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571795 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT FOLLOWING LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT THEY EXPERIENCED A "POSSIBLE "INFECTION" NEAR THE GROIN." THE PATIENT WAS HOSPITALIZED FOR AN EXTENDED PERIOD AND REQUIRED SEVERAL MEDICATIONS. THE LEADLESS IPG WAS SUCCESSFULLY IMPLANTED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24519748 ↗
• DeathFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED ASYSTOLE AND A SUSPECTED PERFORATED RIGHT VENTRICLE. THE PATIENT CODED AND PASSED AWAY.

  Patient problems: Asystole; Cardiac Perforation

  MAUDE report 24444711 ↗
• MalfunctionFeb 17, 2026Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE INTRODUCER EXHIBITED A LEAK AT THE VALVE. UPON ASPIRATING THE VALVE, AIR WAS PULLED INTO THE SYRINGE INSTEAD OF BLOOD. THE PHYSICIAN HAD TO CONTINUE ASPIRATING WHILE PLACING THEIR THUMB OVER THE BACK OF THE INTRODUCER TO ASPIRATE BLOOD THROUGH THE INTRODUCER INSTEAD OF AIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363904 ↗
• MalfunctionFeb 17, 2026Use of Device Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), AFTER FLUSHING, THE TETHER WAS PULLED, BUT IT BECAME STUCK. WHILE PULLING THE TETHER, THERE WAS A MOMENT WHEN IT BECAME TAUT, CAUSING PART OF THE TINES TO DISENGAGE AND RESULTING IN DANCING. THE TETHER WAS FULLY PULLED OUT, BUT THE DANCING DID NOT RESOLVE, SO RETRIEVAL WAS PERFORMED USING A STEERABLE CATHETERAND SNARE. THE LEADLESS IPG WAS ATTEMPTED/NOT USED AND REPLACED. IT WAS ALSO NOTED THAT THE INTRODUCER WAS USED MORE THAN SIX MONTHS AFTER THE USE BY DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363607 ↗
• MalfunctionFeb 17, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE VALVE ON THE INTRODUCER WOULD NOT SEAL DESPITE MULTIPLE ATTEMPTS TO RESEAT. THE INTRODUCER WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362692 ↗
• MalfunctionJan 26, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRODUCER VALVE WAS DAMAGED AND WAS UNABLE TO FLUSH. THE INTRODUCER WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE INTRODUCER WAS UNABLE TO GET BLOOD WHEN PULLING BACK ON SYRINGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177500 ↗
• DeathJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED CARDIAC PERFORATION, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT THE PATIENT PASSED AWAY FROM CARDIAC ARREST.

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

  MAUDE report 24092533 ↗
• MalfunctionJan 14, 2026Break; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE INTRODUCER VALVE WAS DAMAGED AND WAS UNABLE TO ASPIRATE BLOOD ONLY AIR. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066508 ↗
• DeathJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED A CARDIAC PERFORATION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND CARDIAC ARREST. A PERICARDIOCENTESIS AND CARDIOPULMONARY RESUSCITATION WAS REQUIRED BUT THEY WERE UNSUCCESSFUL AND THE PATIENT PASSED AWAY.

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

  MAUDE report 24066503 ↗
• MalfunctionJan 6, 2026Leak/Splash

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), AIR ASPIRATED THROUGH THE INTRODUCER VALVE. ATTEMPTED DILATOR RE-INSERT TO SEAT VALVE LEAFLETS WAS UNSUCCESSFUL. THE INTRODUCER SHEATH WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972591 ↗
• MalfunctionJan 5, 2026Leak/Splash

  IT WAS REPORTED THAT DURING IMPLANT THAT THEY WERE UNABLE TO ASPIRATE AS AIR WAS BEING PULLED IN. THE INTRODUCER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955261 ↗
• MalfunctionDec 23, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), LEAKING WAS NOTED IN THE DELIVERY SYSTEM CUP. IT WAS ALSO NOTED THAT THE INTRODUCER WAS USED MORE THAN SIX MONTHS AFTER THE USE BY DATE. THE DEVICE WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878307 ↗