Assurity™ PM2240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,076 adverse event reports that list this exact device (DI 05414734507073), received between Jun 11, 2018 and Sep 30, 2026 — classified as 84 deaths, 1,829 injuries, 2,162 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (803 reports).

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (P880086); they may or may not involve this specific model.

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.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,076 reports, 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 ↗
• 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 ↗
• MalfunctionSep 9, 2026Failure to Disconnect

  It was reported that the patient presented to hospital for generator change procedure. During the procedure, it was noted that both the right atrial (RA) and right ventricular (RV) leads failed to remove from the header of pacemaker. The pacemaker was explanted and replaced; however, both the RA and RV leads remained implanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683626 ↗
• MalfunctionSep 8, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50680423 ↗
• InjurySep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679868 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679800 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  New information indicates that the pacemaker was explanted and replaced on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679622 ↗
• MalfunctionSep 4, 2026Over-Sensing

  It was reported that patient presented to clinic for follow up. Device evaluation identified oversensing due to noise on the pacemaker (PM), atrial lead, and right ventricular (RV) lead. Subsequent interrogation of the PM revealed recorded episodes of high ventricular rate (HVR). No intervention or procedure was performed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50604690 ↗
• MalfunctionSep 3, 2026No Apparent Adverse Event

  The product was returned without a complaint associated to the product and there is no allegation of a malfunction for this product.

  Patient problems: Insufficient Information

  MAUDE report 50594816 ↗
• InjurySep 2, 2026Failure to Interrogate; No Apparent Adverse Event; No Pacing

  Additional information received indicated the patient was asymptomatic and stable throughout the procedure. Corrected information received indicated the PM was explanted and replaced electively to implant an Aveir leadless system.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576774 ↗
• InjurySep 2, 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 stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572060 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the device is subject to the Assurityand EndurityPacemakers Header Anomaly Advisory issued by Abbott on 15 March 2021.The pacemaker was explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50552419 ↗
• MalfunctionSep 1, 2026No Apparent Adverse Event

  This report is to advise of an event observed during analysis.

  Patient problems: Insufficient Information

  MAUDE report 50550319 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the device is subject to the Assurity and Endurity Pacemakers Header Anomaly Advisory issued by Abbott on 15 March 2021. The patient's pacemaker was prophylactically explanted and replaced. The patient remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535910 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator