Aveir™ LSCR111Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05415067034496), received between Oct 20, 2023 and Sep 30, 2026 — classified as 2 deaths, 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented post-implant procedure for follow-up. Upon device interrogation, the right ventricular leadless pacemaker exhibited high capture threshold and pacing impedance. A small pericardial effusion was noted. As a result. the physician decided to extract the device. During extraction with the retrieval catheter, the pericardial effusion worsened. Pericardial window and cardiothoracic surgery were performed successfully as a result. The patient was stable.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50948348 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an Aveir DR implant procedure on a congenital patient, the physician elected to start the procedure with the right atrium leadless pacemaker (RALP). The RALP was released at the target location. When attempting to manipulate the right ventricle leadless pacemaker (RVLP) with the delivery catheter into the RV, the catheter mechanically dislodged the fixed RALP. The RALP embolized in the left femoral artery. The physician inserted an introducer and retrieval catheter into the patient's right femoral artery and snared the RALP. The RALP was pulled toward the introducer but met resistance in the right femoral artery. Under fluoroscopy, contrast arteriograms showed a laceration in the right femoral artery between the introducer and the RALP. Vascular surgery was initiated to retrieve the RALP and repair the vessel. The patient was stable throughout the surgery and is recovering.

  Patient problems: Vascular Dissection

  MAUDE report 50722116 ↗
• MalfunctionMar 5, 2026Premature Separation

  IT WAS REPORTED THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING SURGERY, THE VENTRICULAR LEADLESS PACEMAKER (LP) DISLODGED TO THE HEPATIC VEIN. DURING RETRIEVAL, THE HELIX ON THE LP DEFORMED. AFTER THE LP WAS REMOVED FROM THE PATIENT, IT SEPARATED FROM THE RETRIEVAL CATHETER PREMATURELY. A DIFFERENT LP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526281 ↗
• InjuryFeb 27, 2026Connection Problem; Premature Separation

  IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE RIGHT VENTRICLE (RV) LEADLESS PACEMAKER (LP) WAS DIFFICULT TO DOCK TO THE DELIVERY CATHETER. AFTER FIXATION AND RELEASE, THE LP BECAME LODGED HORIZONTALLY IN THE TRICUSPID VALVE. MULTIPLE ATTEMPTS TO RETRIEVE THE LP WERE MADE DUE TO DIFFICULTY ATTACHING IT TO THE RETRIEVAL CATHETER. WHEN RETRIEVING THE RV LP WITH THE RETRIEVAL CATHETER, THE RV LP PREMATURELY SEPARATED FROM THE RETRIEVAL CATHETER AND DISLODGED TO THE RIGHT ATRIUM. THE RV LP WAS ABLE TO BE RETRIEVED AND REPLACED TO RESOLVE THE EVENT. THE PROLONGATION OF THE PROCEDURE WAS CLINICALLY SIGNIFICANT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471867 ↗
• DeathNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER RIGHT VENTRICLE LEADLESS PACEMAKER (RVLP) IMPLANTATION A RIGHT VENTRICULOGRAPHY WAS PERFORMED AND REVEALED THAT THE HELIX HAD PROTRUDED OUTSIDE THE HEART AT THE APEX. IT WAS NOTED THAT THE RVLP DID NOT ROTATE DURING SCREWING. AFTER REMOVAL, THE PATIENT'S VITAL SIGNS DETERIORATED, AND AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED PERICARDIAL EFFUSION. DRAINAGE WAS CARRIED OUT, AND FRESH FROZEN PLASMA WAS ORDERED, NO IMPROVEMENT IN VITAL SIGNS WERE OBSERVED SO AN EXTRACORPOREAL MEMBRANE OXYGENATION TREATMENT WAS INITIATED AND THE VITAL SIGNS TEMPORARILY STABILIZED. THE PATIENT'S VITAL SIGNS DETERIORATED AGAIN, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT PASSED AWAY LATER THAT DAY.

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

  MAUDE report 23575064 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1004968. IT WAS REPORTED THAT A PATIENT PRESENTED FOR A RIGHT ATRIAL LEADLESS PACEMAKER (LP) EXPLANT PROCEDURE. PATIENT HAD COMPLAINED ABOUT CHEST PAIN POSSIBLY RELATED TO PREMATURE VENTRICULAR CONTRACTIONS OR HIGH CAPTURE THRESHOLDS. DURING THE EXPLANT, THE TRI-LOOP SNARE DETACHED FROM THE RETRIEVAL CATHETER. THE SNARE WAS SUCCESSFULLY RETRIEVED, BUT THE REST OF THE PROCEDURE WAS ABORTED AND THE LP REMAINED IMPLANTED. PATIENT WAS STABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 23548008 ↗
• MalfunctionSep 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC ON (B)(6) 2025 FOR INITIAL IMPLANT PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEADLESS PACEMAKER (LP) WAS DISLODGED DURING TETHER MODE. WHEN THE RVLP WAS BEING RECOVERED WHILE IT WAS STILL CONNECTED TO THE DELIVERY CATHETER, THE RVLP SEPARATED PREMATURELY FROM THE CATHETER, CAUSING EMBOLISM, AND THE RVLP WAS SITTING FREELY IN THE RIGHT VENTRICLE. WHEN THE RVLP WAS BEING RETRIEVED BY THE RETRIEVAL CATHETER, THE CATHETER WAS LOOSED UP TO RE-ADJUST THE DEVICE FOR RETRIEVAL, BUT THE RVLP SLIPPED AND MIGRATED INTO THE RIGHT ATRIUM. EVENTUALLY, THE RVLP WAS RETRIEVED, NOT IMPLANTED, AND AN ALTERNATE NEAR AT HAND WAS IMPLANTED SUCCESSFULLY INSTEAD. THE FIRST DELIVERY CATHETER USED WAS THEN EXAMINED, WHERE IT WAS FOUND THAT ACTIVATION FAILURE WAS EXHIBITED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948708 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH COMPLAINTS OF FEVER. UPON INVESTIGATION, THE RIGHT VENTRICULAR LEADLESS PACEMAKER (LP) WAS INCORRECTLY IMPLANTED IN THE LEFT VENTRICLE DUE TO AN ATRIAL SEPTAL DEFECT. AN ATTEMPT TO RETRIEVE THE LP WAS PERFORMED WITH THE RETRIEVAL CATHETER. WHEN CROSSING THE ATRIAL SEPTAL DEFECT, A PERFORATION RESULTING IN EFFUSION AND TAMPONADE OCCURRED. THE RETRIEVAL PROCEDURE WAS ABANDONED AND PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22786671 ↗
• DeathJul 9, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER THE LEADLESS (LP) PACEMAKER IMPLANT WAS COMPLETED, THE PATIENT EXPERIENCED CARDIAC ARREST RESULTING IN PULSELESS HEART ACTIVITY. A THORACOTOMY AND CARDIAC MASSAGE WERE PERFORMED. DURING THE CARDIAC MASSAGE, THE LP DISLODGED AND MIGRATED TO THE PULMONARY ARTERY. THE LP WAS UNABLE TO BE RETRIEVED WITH A RETRIEVAL CATHETER DUE TO A STRETCHED HELIX. THE PACEMAKER WAS SURGICALLY REMOVED. THE PATIENT WAS ALERT WITH NORMAL VITAL SIGNS FOLLOWING THE PROCEDURE, HOWEVER, PASSED AWAY A FEW DAYS LATER. THE PHYSICIAN ALLEGED THE PATIENT PASSED AWAY DUE TO A PULMONARY EMBOLISM AND THE PROCEDURE TIME MAY HAVE CONTRIBUTED TO THE PATIENT'S PASSING. THE PHYSICIAN ALLEGED THAT THE ABBOTT PRODUCTS USED WERE NOT RELATED TO THE CARDIAC ARREST OR THE PATIENT DEATH. ADDITIONALLY, IT WAS STATED THAT THE PATIENT EXPERIENCED A PLEURAL EFFUSION. IT IS UNKNOWN IF THE PULMONARY EMBOLISM OR PLEURAL EFFUSION WAS RELATED TO THE ABBOTT PRODUCTS OR THE PROCEDURE.

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

  MAUDE report 22462311 ↗
• MalfunctionJul 1, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO IMPLANT THE RIGHT ATRIAL LEADLESS PACEMAKER (ALP) HOWEVER, THE TETHERS WOULD NOT RELEASE THE ALP, BROKE OFF FROM THE CATHETER, AND REMAINED ON THE DEVICE. RETRIEVAL OF THE ALP WAS ATTEMPTED; HOWEVER, THE SNARE BROKE ON THE CATHETER. THE ALP REMAINS IMPLANTED WITH THE BROKEN TETHERS ATTACHED. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379412 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-14320. IT WAS REPORTED THE PATIENT PRESENTED WITH A LEADLESS PACEMAKER (LP) THAT WAS INTERFERING WITH THE VALVE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE LP, BUT THE HELIX WAS STRETCHED. ECHOCARDIOGRAM SUGGESTED EITHER THE LP OR RETRIEVAL CATHETER HAD RIPPED THE VALVE PILLAR. VALVE REPLACEMENT WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21399820 ↗
• MalfunctionMay 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO IN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE ATRIAL LEADLESS PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLD AFTER FIXATION. THE PHYSICIAN THEN HAD DIFFICULTIES RELEASING THE DEVICE FROM THE DELIVERY CATHETER. ONCE THE DEVICE WAS RELEASED, IT DISLODGED AND MIGRATED TO THE INFERIOR VENA CAVA (IVC). A RETRIEVABLE CATHETER WAS UTILIZED TO RETRIEVE THE DEVICE. DURING EXTRACTION, THE DEVICE SEPARATED PREMATURELY FROM THE RETRIEVABLE CATHETER. ULTIMATELY, THE VASCULAR SURGEON WAS ABLE TO RETRIEVE THE DEVICE FROM THE PATIENT'S BODY. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE'S HELIX WAS SPRUNG AT THE END OF THE RETRIEVAL PROCESS. ULTIMATELY, AN ATRIAL LEADLESS PACEMAKER WAS NOT IMPLANTED. THE PATIENT CONDITION WAS STABLE THROUGHOUT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397392 ↗
• InjuryMay 22, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THE PATIENT PRESENTED FOR AN ATRIOVENTRICULAR NODE ABLATION. FOLLOWING THE PROCEDURE, THE LONGEVITY ESTIMATE ON THE LEADLESS PACEMAKER (LP) DECREASED AND THE CAPTURE THRESHOLD INCREASED. THE PATIENT PRESENTED FOR EXPLANT PROCEDURE ON (B)(6)2024. DURING THE PROCEDURE, THE REPLACEMENT LP WAS IMPLANTED AND EXPLANT OF THE OLD LP WAS ATTEMPTED. THE RETRIEVAL CATHETER FAILED TO CONNECT TO THE DOCKING BUTTON ON THE OLD LP. THE OLD LP WAS DEACTIVATED. AT THE END OF THE PROCEDURE, AN EFFUSION WAS DISCOVERED WHEN THE PATIENT'S BLOOD PRESSURE RAPIDLY DROPPED. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

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

  MAUDE report 19378316 ↗
• MalfunctionNov 2, 2023Premature Separation; Premature Separation

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-51525. IT WAS REPORTED THE PATIENT PRESENTED FOR A LEADLESS PACEMAKER (LP) IMPLANT. DURING THE PROCEDURE AT THE INITIAL LOCATION, AFTER RELEASE, THE LP HAD HIGH CAPTURE THRESHOLDS AND EXHIBITED UNDER SENSING. IT WAS DECIDED TO REPLACE THE DEVICE AND A RETRIEVAL CATHETER WAS OPENED. UPON INITIALLY GRABBING THE LP, THE LP PREMATURELY RELEASED AND MIGRATED TO THE PULMONARY ARTERY. THE LP WAS ABLE TO BE SNARED AND REMOVED FROM THE PATIENT. IMPLANT ATTEMPT WAS ABANDONED. THE PATIENT WAS STABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 18060463 ↗
• MalfunctionOct 20, 2023Premature Separation; Premature Separation

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT PRESENTED FOR A PACEMAKER REPLACEMENT PROCEDURE. DURING SURGERY, THE LEADLESS PACEMAKER (LP) EXHIBITED HIGH CAPTURE THRESHOLDS AFTER BEING TETHERED. DURING RETRIEVAL OF THE LP, THE SNARE ON THE RETRIEVAL CATHETER LOOSENED AND THE LP MIGRATED TO THE PULMONARY ARTERY. THE LP WAS SUCCESSFULLY EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Embolism/Embolus

  MAUDE report 17981343 ↗