CapSure VDD-2 Lead (5038L, 5038S, 5038), Service Kit-Pacemaker Repair Kit (5873C)

• 3 recalls, same reason

  • Ongoing Z-0303-2027 FDA Not yet classified ·initiated 24 Sep 2026 ·on shared PMA P890003
  • Ongoing Z-0304-2027 FDA Not yet classified ·initiated 24 Sep 2026 ·on shared PMA P890003
  • Ongoing Z-0302-2027 FDA Not yet classified ·initiated 24 Sep 2026 ·on shared PMA P890003

  Software problem has the potential for an inaccurate displayed longevity estimate.

• 2 recalls, same reason

  • Ongoing Z-2168-2025 FDA Class II ·initiated 18 Jun 2025 ·on shared PMA P890003
  • Ongoing Z-2169-2025 FDA Class II ·initiated 18 Jun 2025 ·on shared PMA P890003

  In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

• 2 recalls, same reason

  • Ongoing Z-2127-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P890003
  • Ongoing Z-2128-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P890003

  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-2506-2020 FDA Class II ·initiated 4 Jun 2020 ·on shared PMA P890003
  • Ongoing Z-2505-2020 FDA Class II ·initiated 4 Jun 2020 ·on shared PMA P890003

  There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

• • Terminated Z-0845-2019 FDA Class II ·initiated 17 Jan 2019 ·on shared PMA P890003

  There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

• 2 recalls, same reason

  • Terminated Z-0399-2018 FDA Class II ·initiated 14 Jul 2017 ·on shared PMA P890003
  • Terminated Z-0400-2018 FDA Class II ·initiated 14 Jul 2017 ·on shared PMA P890003

  Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

• • Terminated Z-2209-2010 FDA Unclassified (pre-2012) ·initiated 11 Jun 2010 ·on shared PMA P890003

  Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.

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

Full name

CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C)

Trade Name

Model 9790C Programmer and Model 9891 Pe Software

Generic Name

implantable pacemaker Pulse-generator

PMA Number

P890003 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S055

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• What is the CapSure VDD-2 Lead primarily used for in cardiac pacing systems?

  The CapSure VDD-2 Lead is designed for **biventricular pacing**, delivering electrical stimulation to the right atrium, right ventricle, and coronary sinus. This synchronized pacing helps improve cardiac function in patients with heart failure by coordinating contractions between the heart’s chambers, reducing symptoms like congestion and fatigue.

• Are the CapSure VDD-2 Leads single-use or reusable, and how does the Service Kit-Pacemaker Repair Kit (5873C) differ?

  The CapSure VDD-2 Leads (5038L, 5038S, and 5038) are **sterile and intended for single-use implantation only**, adhering to medical best practices for implanted devices. In contrast, the **Service Kit-Pacemaker Repair Kit (5873C)** is explicitly designed for **reusable maintenance procedures**, allowing technicians to repair or service pacemakers without replacing the entire lead system.

• Which Medtronic pulse generators and programmers are compatible with these leads?

  The CapSure VDD-2 Leads are approved for use with **Medtronic’s Synergyst II pulse generators (Models 7070 and 7071)** and the **Model 9710 Programmer with the MemoryMod® 9739A module**. Compatibility ensures proper pacing functionality and programming capabilities for biventricular therapy.

• How should these leads be stored before implantation, and what safety considerations apply?

  Since the CapSure VDD-2 Leads are **sterile and single-use**, they must be stored in their original packaging until implantation to maintain sterility. Additionally, while not explicitly MRI-safe for all models, they adhere to **Medtronic’s MRI safety guidelines for specific configurations**, which should be verified before any MRI procedures involving the patient.