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Capsure® Vdd-2 5038-65

by Medtronic, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

Recall on shared PMA P890003; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169325685 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

10 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2169-2025 FDA Class II initiated 18 Jun 2025 on shared PMA P890003
    • Ongoing Z-2168-2025 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-2128-2025 FDA Class II initiated 17 Jun 2025 on shared PMA P890003
    • Ongoing Z-2127-2025 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-2505-2020 FDA Class II initiated 4 Jun 2020 on shared PMA P890003
    • Ongoing Z-2506-2020 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-0400-2018 FDA Class II initiated 14 Jul 2017 on shared PMA P890003
    • Terminated Z-0399-2018 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Capsure® Vdd-2
Generic Name
Endocardial/interventricular septal pacing lead
Model / Reference
5038-65
Primary DI / UDI-DI
00643169325685
PMA Number
FDA Product Code
NVN, DTB
GMDN Term
Endocardial/interventricular septal pacing lead
Device Class
Class III
Regulation Number
870.3680
GUDID distribution status
Not in Commercial Distribution
Size
Length — 65.0 Centimeter

Related devices

Cleared under the same submission (P890003)

Show all (12)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Combination Product
  • Serial Number

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No