Aveir™ LSN25501Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 05415067034847), received between Jul 13, 2022 and Sep 23, 2026 — classified as 5 deaths, 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Too Rigid or Stiff; Difficult to Advance

  It was reported that the patient presented for an implant procedure. During the procedure, it was difficult to advance the introducer smoothly into the inferior vena cava. The physician felt it was too stiff. While advancing the introducer, the patient experienced a vasovagal reaction with hypotension. The physician attempted the leadless pacemaker implant; however, the delivery catheter could not be placed in the target location as the docking button and docking cap separated and forward pressure could not be applied. Medication was administered to address the vasovagal reaction and the procedure was aborted. There were no patient consequences and the patient was stable.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 50869971 ↗
• InjurySep 17, 2026Break; Fluid/Blood Leak

  During an initial implant procedure on (b)(6) 2026, it was reported that the introducer broke while inserting the valve bypass tool and blood started pouring out. The physician pulled the broken introducer out and hemostasis was achieved. The introducer was exchanged and the procedure was completed successfully. The patient was stable throughout the procedure.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50804274 ↗
• InjurySep 12, 2026Fluid/Blood Leak

  Patient problems: Embolism/Embolus

  MAUDE report 50745013 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A RIGHT VENTRICULAR LEADLESS PACEMAKER (RVLP), THE PHYSICIAN EXPERIENCED DIFFICULTY NAVIGATING THE DEVICE TO THE RIGHT VENTRICLE. AFTER THE DEVICE CROSSED THE TRICUSPID VALVE AND WAS UNTETHERED, ECHOCARDIOGRAPHY REVEALED SEVERE TRICUSPID REGURGITATION. IT WAS SUSPECTED THAT THE RVLP COULD BE INTERACTING WITH THE VALVE. IT WAS ALSO SUSPECTED THAT THE SEPTAL LEAFLET OF THE TRICUSPID VALVE HAD BEEN DAMAGED DURING THE PROCEDURE. THE RVLP REMAINS IMPLANTED. DURING REMOVAL OF THE INTRODUCER, TISSUE WAS OBSERVED ON THE INTRODUCER. THE PATIENT WAS RECOVERING FOLLOWING THE PROCEDURE.

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

  MAUDE report 25713649 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE ON (B)(6) 2026. DURING PROCEDURE, IT WAS FOUND THAT THE INTRODUCER EXHIBITED NO BACKFLOW WHEN BEING FLUSHED AND EXHIBITED SIGNS OF AIR LEAKAGE INTO THE TOOL. A STRUCTURAL ISSUE ON THE HEMOSTASIS VALVE OF THE INTRODUCER WAS ALLEGED. THE INTRODUCER WAS NOT USED AND REPLACED TO PROCEED WITH THE PROCEDURE. THEN, FLUOROSCOPY IMAGING WAS PERFORMED, AND AIR WAS SUSPECTED TO BE PRESENT IN THE RIGHT ATRIUM AND RIGHT VENTRICULAR OUTFLOW TRACT. THE AIR WAS DISSIPATED EVENTUALLY, AND THE PROCEDURE WAS CONCLUDED WITH NO FURTHER PATIENT CONSEQUENCES. PATIENT CONDITION WAS STABLE POST OPERATION.

  Patient problems: Embolism/Embolus

  MAUDE report 25660801 ↗
• InjuryJun 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AVEIR IMPLANT, THE PHYSICIAN INSERTED AN AVEIR INTRODUCER INTO THE IMPLANT SITE AND NOTICED THAT THE INTRODUCER WAS SUCKING IN AIR TO THE PATIENT THROUGH THE VALVE. ASPIRATING THE EXCESS AIR WAS ATTEMPTED TO BE ASPIRATED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE INTRODUCER ON (B)(6) 2026. THE PATIENT WAS STABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 25383104 ↗
• InjuryMay 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR AVEIR IMPLANT PROCEDURE. DURING IMPLANT, IT WAS NOTED THAT THE INTRODUCER FAILED TO BE ASPIRATED. UPON EXAMINATION, IT WAS OBSERVED THAT A THROMBUS HAD FORMED WITHIN THE INTRODUCER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE INTRODUCER ON (B)(6) 2026. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25303457 ↗
• InjuryMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRODUCER, WIRE, AND DILATOR WERE INTRODUCED INTO PATIENT¿S VASCULAR FOR A LEADLESS PACEMAKER IMPLANT. AIR KEPT COMING OUT OF THE SYRINGE AFTER TAKING OUT THE DILATOR AND WIRE AND ASPIRATING. THE DILATOR WAS PUT BACK IN AND THEN ALSO REMOVED WITH THE SAME RESULTS. THE PHYSICIAN PUT THEIR THUMB OVER THE OPENING OF THE INTRODUCER, AND BOTH AIR AND BLOOD PULLED BACK WHEN ASPIRATING. THE DELIVERY CATHETER WAS THEN INTRODUCED INTO THE SYSTEM. AT THIS TIME, THE AIR WAS VISUALIZED ON FLUOROSCOPY, SYSTEM WAS TAKEN OUT, AND THE INTRODUCER WAS REPLACED. IT WAS SUSPECTED THAT THE VALVE ON THE INTRODUCER WAS LEAKY AND INTRODUCED AIR INTO THE SYSTEM. PATIENT HAD NO OTHER CONSEQUENCES.

  Patient problems: Embolism/Embolus

  MAUDE report 25225155 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE ON (B)(6) 2026. DURING PROCEDURE, IT WAS FOUND THAT THE INTRODUCER EXHIBITED AIR ASPIRATION, AND THE LARGE AMOUNT OF AIR WAS ABSORBED INTO THE BODY AFTER ENTERING. IT WAS ALSO FOUND THAT THE HEMOSTASIS VALVE ON THE INTRODUCER APPEARED TO BE INVERTED. A REPLACEMENT INTRODUCER WAS USED BUT THE SAME ISSUES WERE NOTED. AS THERE WERE NO SERIOUS CONSEQUENCES NOTED, THE PROCEDURE WAS PERFORMED AS PLANNED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Embolism/Embolus

  MAUDE report 24974401 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE ON (B)(6) 2026. DURING PROCEDURE, IT WAS FOUND THAT THE INTRODUCER EXHIBITED AIR ASPIRATION, AND THE LARGE AMOUNT OF AIR WAS ABSORBED INTO THE BODY AFTER ENTERING. IT WAS ALSO FOUND THAT THE HEMOSTASIS VALVE ON THE INTRODUCER APPEARED TO BE INVERTED. A REPLACEMENT INTRODUCER WAS USED BUT THE SAME ISSUES WERE NOTED. AS THERE WERE NO SERIOUS CONSEQUENCES NOTED, THE PROCEDURE WAS PERFORMED AS PLANNED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Embolism/Embolus

  MAUDE report 24973813 ↗
• DeathApr 16, 2026Obstruction of Flow

  IT WAS REPORTED THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING SURGERY, THE INTRODUCER WAS INSERTED INTO THE PATIENT AND WAS UNABLE TO ASPIRATE. A WIRE WAS INSERTED AND CLEARED THE OBSTRUCTION. THE PATIENT'S HEART RATE DROPPED, THEY DEVELOPED RESPIRATION ISSUES, AND THE PULSE DROPPED. THE PATIENT DECEASED.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 24896892 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PUNCTURE SITE INFECTION DAYS AFTER THE IMPLANT PROCEDURE. THE INFECTION WAS ADDRESSED WITH MEDICATION AND INCISIONAL DRAINAGE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24861284 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE LEADLESS PACEMAKER (LP) SYSTEM IMPLANT PROCEDURE, DUE TO PATIENT'S SMALL HEART ANATOMY, IT WAS DIFFICULT TO ACCESS THE RIGHT VENTRICULAR (RV). WHEN THE LP WAS MANEUVERED INTO A GOOD POSITION IN THE RV, THE INTRODUCER WAS LOWERED AND THE LP POSITIONING WAS LOST. AT THAT TIME THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE RESULTING IN SYNCOPE. A MEDICATION WAS ADMINISTRATED TO STABILIZE THE PATIENT. THE LP SYSTEM WAS EXPLANTED AND THE PHYSICIAN ELECTED TO IMPLANT A TRADITIONAL PACEMAKER.

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 24854160 ↗
• DeathFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE LEADLESS PACEMAKER (LP) SYSTEM IMPLANT PROCEDURE, THE INTRODUCER WAS INTRODUCED TO THE PATIENT AND WITHIN MINUTES, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND BECAME UNSTABLE. THE WIRE USED WITH THE INTRODUCER WAS A STIFF PRODUCT AND THE ATRIAL APPENDAGE WAS PERFORATED. THE WIRE USED WAS NOT AN ABBOTT PRODUCT. AN EFFUSION WAS OBSERVED ON THE ECHOCARDIOGRAM. OPEN HEART SURGERY WAS PERFORMED TO STABILIZE THE PATIENT. DAYS FOLLOWING THE PROCEDURE, THE PATIENT PASSED AWAY.

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

  MAUDE report 24470643 ↗
• InjuryFeb 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  CORRECTED INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATED THE REPORTED EVENT OF VENOUS RUPTURE DID NOT OCCUR. THE INTRODUCER WAS ONLY DAMAGED DURING THE PROCEDURE. THE PATIENT IS IN STABLE CONDITION AND DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 24238430 ↗
• InjuryFeb 2, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VENOUS RUPTURE OCCURRED WHEN THE INTRODUCER WAS ADVANCED INTO THE PATIENT. THE INTRODUCER WAS REMOVED. DILATION WAS PERFORMED AND A NEW INTRODUCER WAS ABLE TO BE ADVANCED INTO THE RIGHT ATRIUM. ANOTHER VENOUS RUPTURE OCCURRED WHILE ADVANCING THE SECOND INTRODUCER. THE EVENT WAS SUSPECTED TO BE DUE TO DUE TO TORTUOUS ANATOMY. NO INTERVENTION WAS REQUIRED TO RESOLVE THE EVENT. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 24238366 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT TO ADDRESS THE BLEEDING AN INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24074007 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PHYSICIAN HAD AN ISSUE WITHDRAWING A LEADLESS PACEMAKER INTRODUCER FROM A PATIENT'S FEMORAL VEIN DURING AN IMPLANT PROCEDURE. PHYSICIAN SUSPECTED IT WAS DUE TO A VENOUS SPASM. THE INTRODUCER WAS EVENTUALLY ABLE TO BE REMOVED, AND A BALLOON DILATION WAS PERFORMED UNDER ANGIOGRAPHY. THE PROCEDURE WAS PRECAUTIONARILY SUSPENDED WITHOUT IMPLANT TAKING PLACE. PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 24030910 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL IMPLANT PROCEDURE OF AN ATRIAL LEADLESS PACEMAKER (ALP), IT WAS REPORTED THAT THE INTRODUCER SHEATH SLIPPED INTO THE ILIAC VEIN DUE TO MANEUVERING BY THE PHYSICIAN. CONTRAST IMAGING NOTED THE VEIN WAS RUPTURED. THE PHYSICIAN REPAIRED THE VEIN WITH A STENT. THE CASE WAS ABANDONED, AND THE PATIENT WAS STABLE DURING THE WHOLE PROCESS.

  Patient problems: Perforation of Vessels

  MAUDE report 23959848 ↗
• DeathDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING SURGERY, THE DELIVERY CATHETER ROSE UP UNEXPECTEDLY AND DISLODGED THE VENTRICULAR LEADLESS PACEMAKER (LP). WHILE THE LP, DELIVERY CATHETER, AND INTRODUCER WERE BEING REMOVED, THE PATIENT CODED AND PASSED AWAY.

  Patient problems: Arrhythmia

  MAUDE report 23889197 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE CONCLUSION OF THE IMPLANT PROCEDURE OF A LEADLESS PACEMAKER SYSTEM, THE FEMORAL VEIN INTRODUCER WAS REMOVED AND THE IMPLANT SIT BEGAN TO BLEED. COMPRESS MEASURES WERE APPLIED TO THE SITE AND PRIOR TO SURGICAL INTERVENTION BEING NEEDED HEMOSTASIS WAS REACHED. THE SUSPECTED CAUSE OF THE BLEEDING WAS A FISTULA. THE PATIENT WAS STABLE AND NO FURTHER INTERVENTION WAS PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 23819379 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR LEADLESS PACEMAKER WAS INADEQUATELY FIXATED. AFTER FIXATING, LOSS OF SENSING WAS OBSERVED. FLUOROSCOPY IMAGING SHOWED THAT THE DEVICE HAD DISLODGED AND MIGRATED TO THE RIGHT PULMONARY ARTERY/LUNG. RETRIEVAL OF THE DEVICE WAS ATTEMPTED. WHILE RETRIEVING, THE DEVICE'S HELIX GOT STUCK TO THE PULMONIC VALVE. AN INTRODUCER WAS UTILIZED TO ATTEMPT REMOVING THE DEVICE, AND BY DOING SO ITS HELIX WAS STRETCHED. IT WAS THEN WHEN THE PATIENT'S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS OBSERVED VIA ECHOCARDIOGRAM. CARDIAC TAMPONADE WAS NOTED AS WELL. PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS STABILIZED. THE DEVICE WAS RETRIEVED, AND THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

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

  MAUDE report 23759677 ↗
• MalfunctionNov 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR INITIAL IMPLANT PROCEDURE ON (B)(6) 2025. DURING PROCEDURE, IT WAS FOUND THAT THE INTRODUCER TOOL ASPIRATED AIR WHILE BEING FLUSHED. THE INTRODUCER WAS NOT USED AND AN ALTERNATE NEAR AT HAND WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646958 ↗
• InjuryOct 29, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN INITIAL IMPLANT OF A RIGHT VENTRICULAR AVEIR LEADLESS PACEMAKER (RVLP) ON (B)(6) 2025. DURING THE IMPLANT, THERE WAS DIFFICULTY INSERTING THE INTRODUCER SHEATH OVER THE WIRE THROUGH THE RIGHT ILIAC VEIN (IVC-RA) AND IT WAS NOTED THAT THE SHEATH WAS KINKED. AFTER MANEUVERING THE INTRODUCER, THE PHYSICIAN WAS ABLE TO ADVANCE THE INTRODUCER UP TO THE IVC-RA JUNCTION. CONTRAST SHOTS WERE TAKEN UPON INTRODUCING THE RVLP AND DELIVERY CATHETER (DC) INTO THE RIGHT VENTRICLE AND IT WAS DECIDED TO PULL THEM BACK AND RE-ADVANCE. POST RE-ADVANCING THE RVLP AND DC, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND SUPRAVENTRICULAR TACHYCARDIA (SVT). AN ULTRASOUND WAS PERFORMED AND NO CARDIAC PERFORATION WAS NOTED. THE SVT WAS SUCCESSFULLY CONVERTED TWICE USING CARDIOVERSION. HYPOTENSION CONTINUED AND WAS TREATED VIA CARDIOPULMONARY RESUSCITATION (CPR). THE PATIENT EXPERIENCED A BROKEN RIB FROM THE CPR. A MEDICAL EMERGENCY RESPONSE TEAM (MERT) WAS CALLED, AND THEY PERFORMED A BLOOD GAS TEST WHICH SUGGESTED THERE WAS A VENOUS BLEED. THE PHYSICIAN ELECTED TO REMOVE THE RVLP AND DC AND CLOSE THE WOUND. IVC BLEED WAS RULED OUT VIA VENOGRAM, AND MORE DIS

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 23418657 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINAGE FROM THE IMPLANT INCISION SITE POST IMPLANT. THE INCISION SITE WAS SUTURED. DRAINAGE WAS NOTED FROM THE SITE AGAIN. THE PHYSICIAN ELECTED TO MONITOR THE INCISION. THE PATIENT WAS STABLE.

  Patient problems: Seroma

  MAUDE report 23364319 ↗