Concerto II, Maximo II, Protecta and Consulta Implantable Cardioverter Defibrillators

• 2 recalls, same reason

  • Ongoing Z-2127-2025 FDA Class II ·initiated 17 Jun 2025 ·via P010031, on the same PMA
  • Ongoing Z-2128-2025 FDA Class II ·initiated 17 Jun 2025 ·via P010031, on the same PMA

  A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

• 4 recalls, same reason

  • Ongoing Z-1526-2021 FDA Class II ·initiated 6 Apr 2021
  • Ongoing Z-1527-2021 FDA Class II ·initiated 6 Apr 2021
  • Ongoing Z-1528-2021 FDA Class II ·initiated 6 Apr 2021
  • Ongoing Z-1525-2021 FDA Class II ·initiated 6 Apr 2021

  A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

• • Ongoing Z-1306-2021 FDA Class I ·initiated 3 Feb 2021

  A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

• 3 recalls, same reason

  • Terminated Z-0927-2021 FDA Class II ·initiated 15 Nov 2020
  • Terminated Z-0926-2021 FDA Class II ·initiated 15 Nov 2020
  • Terminated Z-0928-2021 FDA Class II ·initiated 15 Nov 2020

  Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

• • Terminated Z-0667-2009 FDA Unclassified (pre-2012) ·initiated 25 Jul 2008

  Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Full name

Concerto Ii Crt-D & Various Families of Maximo Ii & Protecta Crt-Ds' Various Families of Consulta Icds

Trade Name

Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization

Generic Name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

PMA Number

P010031 ↗

FDA Product Code

NIK

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• Byrel Programable Pacemaker

  Class III

  FDA PMA P780009 Active Approved 27 Mar 1979

• Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators Open recall

  Class III

  FDA PMA P980016 Active Approved 9 Oct 1998

• CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead

  Class III

  FDA PMA P850089 Active Approved 29 Jul 1986

• Gem Model 7227 Implantable Cardioverter Defibrillator

  Class III

  FDA PMA P900061 Active Approved 11 Feb 1993

• Select Secure Lead Model 3830

  Class III

  FDA PMA P030036 Active Approved 3 Aug 2005

• Medtronic(R) Model 4003M, 4503M, 4504M, & 4523 Pacing

  Class III

  FDA PMA P830061 Active Approved 29 Jul 1986

See all devices from Medtronic Cardiac Rhythm Disease Management →

• What is the primary function of these CRT-D devices?

  These devices function as automatic implantable cardioverter defibrillators that provide both ventricular antitachycardia pacing and ventricular defibrillation to treat life-threatening ventricular arrhythmias.

• Are these devices suitable for all heart failure patients?

  No, these devices are specifically indicated for patients with moderate to severe heart failure (NYHA functional class III or IV) who remain symptomatic despite stable, optimal medical therapy, and who have a left ventricular ejection fraction of 35% or less and a QRS duration of 130 ms or greater.

• What regulatory authorization do these devices hold?

  These devices are authorized under the FDA Premarket Approval (PMA) process, specifically under PMA number P010031.