AssurityRecalls & reported problems across all models

We found 4 models of Assurity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 4,504 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 104 deaths, 1,988 injuries, 2,411 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (847 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

Assurity 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. Mar 15, 2021Open, Classified

   Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

   Z-1530-2021 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported Assurity problems

Assurity models

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

• Assurity™ PM2240

  Pulse generator, permanent, implantable
  1 recall84 deaths4,076 reports
• Assurity™ PM1240

  Pulse generator, permanent, implantable
  1 recall20 deaths306 reports
• Assurity™ PM2260

  Pulse generator, permanent, implantable
  1 recall109 reports
• Assurity™ PM1260

  Pulse generator, permanent, implantable
  13 reports

Recent Assurity adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955067 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the patient's pacemaker exhibited an Electronic Performance Indicator (EPI) alert, resulting in premature battery depletion. Additional information was unavailable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950080 ↗
• MalfunctionSep 28, 2026Over-Sensing; Pacing Problem

  It was reported that the patient presented remotely via Merlin.net. It was noted that pacemaker exhibited far-field R-wave over-sensing, which resulted in inappropriate mode switch. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911135 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's pacemaker, right atrial (RA) lead and right ventricular (RV) lead were explanted on (b)(6) 2026 due to infection. Temporary pacemaker was placed until the infection was resolved; the patient was subsequently implanted with a new pacemaker system on (b)(6) 2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50910666 ↗
• InjurySep 24, 2026Premature Discharge of Battery

  Following the Electronics Performance Indicator (EPI), an alert was received by the clinician and device was explanted. The patient condition was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889193 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Mode Switch

  It was reported that the patient presented in clinic for a follow-up. Upon interrogation, the pacemaker was found to be in backup VVI mode. Additionally, electrogram (EGM) data was absent from the rhythm recordings. Device restoration was performed. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869506 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported via product return that the patient with the pacemaker and Right Ventricular lead implanted passed away due to hypertension, cardiovascular disease, and effusions. Further information was requested but has not yet been received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812176 ↗
• InjurySep 16, 2026Premature Discharge of Battery; Failure to Interrogate

  It was reported that the patient's pacemaker was unable to be interrogated due to premature battery depletion. It was suspected that the pacemaker had a header issue. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792458 ↗
• MalfunctionSep 16, 2026Unexpected Mode Switch

  It was reported during in clinic follow up that the patient's pacemaker went into backup mode due to event queue overflow. Programming changes were made and the device was restored. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790211 ↗
• MalfunctionSep 14, 2026Loose or Intermittent Connection

  It was reported that the patient presented for a pacemaker implant procedure. During the procedure, the pacemaker's set screw could not be tightened. As a result, the pacemaker was not implanted. The physician completed the procedure using an alternate pacemaker. No adverse patient conditions were reported. The patient was discharged following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748000 ↗
• InjurySep 11, 2026Unexpected Mode Switch

  Patient problems: Insufficient Information

  MAUDE report 50744669 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  New information indicates that the pacemaker was explanted and replaced. The patient condition was stable, before, during and after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744241 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50721624 ↗
• MalfunctionSep 9, 2026Premature Discharge of Battery

  Following the Electronics Performance Indicator (EPI), an alert was received by the clinician and awaiting device explant.  Further information was requested, but not yet available. The patient condition was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695272 ↗
• MalfunctionSep 9, 2026Failure to Disconnect

  It was reported that the patient presented for a generator change procedure. During the procedure, it was noted that the right ventricular (RV) lead and right atrial (RA) lead could not be removed from the pacemaker header. The physician injected saline into the pacemaker header in an attempt to remove the leads. The RA lead was eventually removed; however, the insulation of the RV lead was damaged, and the RV lead could not be removed from the pacemaker header. The physician subsequently capped the RV lead. The existing RA lead and a new RV lead were connected to the new pacemaker, and the old pacemaker was explanted. The patient remained in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685317 ↗

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