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Medtronic Carelink Express™ 2020C1

by Medtronic, Inc. United States GUDID

Product code OSR

Regulatory status

as of 25 Oct 2026

Recall ongoing on a related submission. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994952431 UDI-DIDate23 Sep 2014ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

10 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2169-2025 FDA Class II initiated 18 Jun 2025 via P890003, on the same PMA
    • Ongoing Z-2168-2025 FDA Class II initiated 18 Jun 2025 via P890003, on the same PMA

    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 via P890003, on the same PMA
    • Ongoing Z-2127-2025 FDA Class II initiated 17 Jun 2025 via P890003, 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.

  • 2 recalls, same reason

    • Ongoing Z-2505-2020 FDA Class II initiated 4 Jun 2020 via P890003, on the same PMA
    • Ongoing Z-2506-2020 FDA Class II initiated 4 Jun 2020 via P890003, on the same PMA

    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

    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 via P890003, on the same PMA
    • Terminated Z-0399-2018 FDA Class II initiated 14 Jul 2017 via P890003, on the same PMA

    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 via P890003, on the same PMA

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

Specification

GUDID · synced 23 Oct 2026

Trade Name
Medtronic Carelink Express™
Generic Name
Cardiac pulse generator reader, professional
Model / Reference
2020C1
Primary DI / UDI-DI
00613994952431
PMA Number
FDA Product Code
OSR
GMDN Term
Cardiac pulse generator reader, professional
Device Class
Class III
Commercial Distribution
In Commercial Distribution

Related devices

Category: Cardiac pulse generator reader, professional

Cleared under the same submission (P890003)

Show all (12)

Similar devices

Also classified as Cardiac pulse generator reader, professional.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI f59077ef-5402-49a7-bfc7-1c77940a6110 36 fields · synced 23 Oct 2026