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Adapta™ ADVDD01 (UDI 00763000316761)Recalls & reported problems

Medtronic, Inc. · IPG ADVDD01 ADAPTA VDD USA · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000316761), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Interrogate” (1 report).

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

Device problems

  • Failure to Interrogate1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2023Failure to Interrogate; Failure to Interrogate

    IT WAS REPORTED BY THE PATIENT THAT TWO WEEKS POST IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AN INTERMITTENT TELEMETRY ISSUE. THE REMOTE MONITOR DISPLAYED A 2300 GENERAL DIAGNOSTIC CODE. IT WAS ALSO REPORTED THAT THE REMOTE MONITOR HAD A TELEMETRY ISSUE. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE CALLER WAS REFERRED TO CLINIC. THE IPG AND REMOTE MONITOR REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16806029 ↗

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-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-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-1924-2025 · Apr 29, 2025 · Open, Classified
    Azure S DR MRI SureScan, Product number W3DR01
  • Z-2507-2020 · Jun 4, 2020 · Open, Classified
    Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
  • Z-2509-2020 · Jun 4, 2020 · Open, Classified
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
  • 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-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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
  • 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-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.

Other Implantable pulse generator, pacemaker (non-CRT) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.