Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators

• 2 recalls, same reason

  • Ongoing Z-2128-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P980016
  • Ongoing Z-2127-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P980016

  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.

• 2 recalls, same reason

  • Ongoing Z-1801-2023 FDA Class I ·initiated 10 May 2023
  • Ongoing Z-1802-2023 FDA Class I ·initiated 10 May 2023

  There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

• • Ongoing Z-1305-2021 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

• 6 recalls, same reason

  • Terminated Z-2421-2018 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-2417-2018 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-2420-2018 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-2419-2018 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-2418-2018 FDA Class II ·initiated 21 Jun 2018
  • Terminated Z-2416-2018 FDA Class II ·initiated 21 Jun 2018

  Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.

• 2 recalls, same reason

  • Terminated Z-0665-2009 FDA Unclassified (pre-2012) ·initiated 25 Jul 2008
  • Terminated Z-0666-2009 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

• • Terminated Z-0812-04 FDA Unclassified (pre-2012) ·initiated 2 Apr 2004

  Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic Name

Implantable cardioverter defibrillator (non-CRT)

PMA Number

P980016 ↗

FDA Product Code

LWS

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• Byrel Programable Pacemaker

  Class III

  FDA PMA P780009 Active Approved 27 Mar 1979

• Concerto II, Maximo II, Protecta and Consulta Implantable Cardioverter Defibrillators Open recall

  Class III

  FDA PMA P010031 Active Approved 26 Jun 2002

• 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 types of patients is this device intended for, and how does it help them?

  This device is designed for patients who have survived at least one episode of cardiac arrest caused by ventricular tachyarrhythmia or who experience recurrent, poorly tolerated ventricular tachycardia. It helps by continuously monitoring the heart and delivering electrical shocks or pacing therapies to correct life-threatening abnormal heart rhythms, such as ventricular tachycardia or ventricular fibrillation, thereby preventing sudden cardiac death.

• Is this device single-use or reusable, and what does that mean for maintenance?

  This device is intended for **permanent implantation** in patients, meaning it is not single-use or reusable in the traditional sense. Once implanted, it remains in the patient’s body for long-term use, requiring periodic follow-up and battery checks by a clinician. The system includes replaceable components like leads (e.g., Model 6940 CapSureFix lead) that may need replacement over time, but the core device itself is not designed for removal and reuse.

• What software and accessories are included with this device, and how do they function?

  The system includes the **Model 7271 GEM DR Implantable Cardioverter Defibrillator**, **Model 9960 GEM DR application software** (used for programming and monitoring the device), the **Model 6940 CapSureFix lead** (for electrical signal transmission), and a **Model 9466 patient magnet** (which temporarily disables the device for MRI or diagnostic procedures). The software enables clinicians to configure therapies and review patient data, while the magnet provides safety during procedures requiring magnetic fields.

• How is this device regulated, and what does that mean for clinicians or buyers?

  This device is classified as **Class III** under FDA regulations and received **PMA approval (P980016)** in 1998, indicating it undergoes rigorous review for safety and effectiveness. Clinicians or buyers should confirm compatibility with their institution’s protocols and ensure proper training for implantation, programming, and follow-up, as this is a high-risk medical device requiring specialized expertise.