Adapta™ ADSR01 (UDI 00643169709041)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169709041), received between Feb 8, 2018 and Jan 26, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (3 reports).

16 other recalls cover devices cleared under the same FDA submission (P980035); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IPG WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176248 ↗
• InjuryMay 8, 2024Premature Discharge of Battery; High impedance; Premature Discharge of Battery; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH CAPTURE MANAGEMENT PACING OUTPUTS WHICH DEPLETED THE BATTERY AND ALSO HAD HIGH BATTERY IMPEDANCE. THE IPG WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19266626 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18757453 ↗
• MalfunctionJun 20, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161281 ↗
• InjuryAug 12, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE IN THE THIRTIES BEAT PER MINUTE (BPM) EVEN THOUGH THE PACEMAKER IS SET AT LOWER RATE OF SIXTY BEATS PER MINUTE. THE PATIENT IS BEING EVALUATED FOR SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope

  MAUDE report 10395179 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION AND EROSION. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9600350 ↗
• MalfunctionAug 24, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE LOWER THAN THE PROGRAMMED LOWER RATE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 8928726 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH VEGETATION, POSSIBLE ABSCESS FORMATION, SEPSIS, (B)(6), ACUTE RESPIRATORY FAILURE WITH HYPOXIA, SEPTIC EMBOLISM, CHRONIC SYSTOLIC HEART FAILURE, ENDOCARDITIS, LOWER BACK PAIN AND GENERALIZED FEVERS. THE PATIENT DEVELOPED OMINOUS RHYTHMS INCLUDING SYMPTOMATIC BRADYCARDIA, SINOATRIAL DYSFUNCTION AND HIGH ATRIOVENTRICULAR BLOCK. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE SINGLE CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND A TRICUSPID VALVE REPLACEMENT WAS PERFORMED. A TEMPORARY PACING RIGHT VENTRICULAR (RV) LEAD WAS PLACED. OVER THE ENSUING WEEK IT WAS NOTED PUS WAS EMANATING FROM THE TEMPORARY LEAD WITH TENDERNESS NOTED. THE PATIENT UNDERWENT DEBRIDEMENT AND FLAP CLOSURE. THE PATIENT DEVELOPED HEMATOMA WHICH WAS SUBSEQUENTLY EVACUATED. A COMPUTERIZED TOMOGRAPHY (CT) OF THE CHEST SHOWED INDICATION OF SEPTIC EMBOLIC DISEASE AND MILD PULMONARY EDEMA WITH BIBASILAR ATELECTASIS AND DIFFUSE BODY WALL ANASARCA. THE CHEST DEBRIDEMENT SHOWED FOCAL NECROTIZING INFLAMMATION, FAT NECROSIS AND HEMORRHAGE. THE STATUS OF THE TEMPORARY PACING LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS

  Patient problems: Arrhythmia; Bradycardia; Embolism; Endocarditis; Exit Block; Fever; Heart Failure; Hypoxia; Inflammation; Necrosis; Pain; Pulmonary Edema; Respiratory Failure; Sepsis; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 8806564 ↗
• MalfunctionFeb 7, 2019Battery Problem; Battery Problem: High Impedance; Battery Problem; Battery Problem: High Impedance

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOW BATTERY VOLTAGE AND HIGH BATTERY IMPEDANCE PRIOR TO USE. THE IPG WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8314322 ↗
• MalfunctionJan 16, 2019Failure to Interrogate; Output Problem; Failure to Interrogate; Output Problem

  IT WAS REPORTED THAT THERE WERE PROBLEMS INTERROGATING THE IMPLANTABLE PULSE GENERATOR (IPG) AND SOME ELECTROGRAMS (EGM) WERE NOT PRESENT. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) PACING LEAD EXHIBITED OUT OF RANGE LEAD IMPEDANCE THAT TRIGGERED A WARNING. THE IPG AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253628 ↗
• InjuryMay 24, 2018Failure to Capture; Mechanical Problem; Failure to Capture; Mechanical Problem

  IT WAS REPORTED THAT A LEAD REVISION PROCEDURE WAS DONE TO REPLACE THE RIGHT VENTRICULAR (RV) LEAD WHICH EXHIBITED HIGH THRESHOLDS. THE FOLLOWING DAY, IT WAS NOTED THERE WAS NO CAPTURE OBSERVED ON THE DEVICE, AND AN X-RAY REVEALED THAT A NEW LEAD HAD NOT BEEN FULLY INSERTED INTO THE HEADER. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM, AND THE LEAD WAS RE-INSERTED INTO THE DEVICE HEADER. ALL MEASUREMENTS TESTED NORMAL, AND THE ISSUE WAS RESOLVED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7541576 ↗
• MalfunctionFeb 8, 2018Loose or Intermittent Connection; Mechanical Problem; Capturing Problem; Loose or Intermittent Connection; Mechanical Problem; Capturing Problem

  IT WAS REPORTED THAT THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) WAS UNSUCCESSFUL BECAUSE THE SET SCREW WOULD NOT SECURE THE RIGHT VENTRICULAR (RV) LEAD. THE UNSECURED RV LEAD EXHIBITED INTERMITTENT CAPTURE WITH THE IPG. THE IPG WAS EXPLANTED AND REPLACED. AFTER THE IPG REPLACEMENT, THE RV LEAD CONTINUED TO EXHIBITED NO CAPTURE AND THE LEAD ALSO EXHIBITED HIGH AND UNSTABLE THRESHOLDS. IT WAS NOTED THAT THE PATIENT EXPERIENCED BRADYCARDIA DUE TO THE RV LEAD CAPTURE ISSUES. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7255078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980035. One submission often covers many models, so check the product and lot details in each record.

• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-0809-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
• Z-0808-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
• Z-0807-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number
• Z-0810-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• Z-0806-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Mo
• Z-2120-2011 · Apr 4, 2011 · Terminated
  Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Wit
• Z-1440-2010 · Feb 11, 2010 · Terminated
  Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects,

…and 1 more.