AveirRecalls & reported problems across all models
St. Jude Medical, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Aveir model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5,099
- Deaths reported
- 211
- Injuries reported
- 1,583
- Recalls
- 2
We found 10 models of Aveir by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 5,099 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2022 and Sep 30, 2026 — classified as 211 deaths, 1,583 injuries, 3,305 malfunctions.
The most frequently reported specific device problem is “Stretched” (994 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Reports received per month, all models
Aveir 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.
- Feb 15, 2025Open, Classified
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Z-1557-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Feb 5, 2024Open, Classified
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Z-1695-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Aveir problems
Device problems
- Stretched994
- Device Dislodged or Dislocated931
- Adverse Event Without Identified Device or Use Problem663
- Failure to Capture659
- Capturing Problem514
- Premature Separation464
- Separation Failure393
- Low impedance316
Patient problems
- No Clinical Signs, Symptoms or Conditions3,072
- Embolism/Embolus740
- Pericardial Effusion665
- Cardiac Perforation593
- Arrhythmia506
- Low Blood Pressure/ Hypotension378
- Cardiac Tamponade307
- Discomfort188
Aveir models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aveir™ LSP112VLeadless pacemaker2 recalls73 deaths1,626 reports
- Aveir™ LSP202VLeadless pacemaker1 recall39 deaths1,214 reports
- Aveir™ LSP201ALeadless pacemaker15 deaths1,163 reports
- AVEIR™ LSP203ALeadless pacemaker6 deaths440 reports
- Aveir™ LSCD201Leadless pacemaker21 deaths321 reports
- Aveir™ LSCD111Leadless pacemaker49 deaths248 reports
- Aveir™ LSN25501Introducer, catheter5 deaths43 reports
- Aveir™ LSL02Leadless pacemaker27 reports
- Aveir™ LSCR111Device, percutaneous retrieval2 deaths15 reports
- Aveir™ LSN25301Introducer, catheter1 death2 reports
Recent Aveir adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952606 ↗MalfunctionSep 30, 2026Premature Separation
It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (LP) exhibited high impedance and capture threshold during mapping. The LP was removed for inspection and prematurely separated from delivery catheter outside the patient. The helix on the LP was also stretched and bent upon inspection. The delivery catheter and LP were replaced to complete the procedure. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951002 ↗MalfunctionSep 30, 2026Stretched; Material Twisted/Bent; Premature Separation
It was reported the patient presented for implant procedure. During surgery, the ventricular Leadless Pacemaker (LP) exhibited high impedance and capture threshold during mapping. The LP was removed for inspection and prematurely separated from delivery catheter outside the patient. The helix on the LP was also stretched and bent upon inspection. The delivery catheter and LP were replaced to complete the procedure. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951000 ↗MalfunctionSep 30, 2026Premature Separation
Patient problems: Embolism/Embolus
MAUDE report 50950795 ↗MalfunctionSep 30, 2026Separation Failure; Connection Problem; Activation Failure; Premature Separation
It was reported that the patient presented in clinic for initial leadless pacemaker implant. During procedure, the catheter failed to go into long tether mode, resulting in it failing to release or dock the leadless pacemaker. Attempts to retract the leadless pacemaker resulted in it prematurely separating, resulting in embolism. A delivery catheter was used to retrieve the leadless pacemaker. Another catheter was used to successfully implant the leadless pacemaker. The patient was stable throughout.
Patient problems: Embolism/Embolus
MAUDE report 50950765 ↗MalfunctionSep 30, 2026Stretched
It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant. During implant, it was observed that the helix of the LP became stretched during mapping. The procedure was completed using an alternate LP on (b)(6)2026. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950435 ↗MalfunctionSep 30, 2026Stretched
It was reported that the patient presented in clinic for Aveir leadless pacemaker (LP) implant procedure. During the implant, it was observed that the helix of the LP was stretched. The procedure was completed using an alternate LP on (B)(6) 2026. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950070 ↗MalfunctionSep 30, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949794 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient presented in clinic for initial leadless pacemaker (LP) implant procedure. During procedure, the LP spontaneously released from the catheter. It was discovered that the tethers on the catheter were slightly misaligned despite the release knob being in the aligned position. The LP was implanted successfully. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949559 ↗MalfunctionSep 30, 2026Stretched; Use of Device Problem; Low impedance
It was reported that the patient presented for an implant procedure. During the procedure, low pacing impedance and inadequate current of injury was observed after device fixation. Re-positioning was attempted; however, the device helix was sprung in the process. The device was not used, and a new one was implanted. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949037 ↗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 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 50948336 ↗MalfunctionSep 29, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941350 ↗MalfunctionSep 29, 2026Failure to Capture; Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941294 ↗MalfunctionSep 29, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938318 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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