CareLink Encore™ 26901

• EUDAMED Basic UDI-DI B-00643169763401 registered 6 Nov 2026 Active
• FDA PMA P890003 decided 12 Aug 1998 Active
• FDA GUDID UDI-DI 00643169763401 listed 20 Nov 2014 Listed

• 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

  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.

1. 4 Jun 2020 Recall initiated FDA recalls Z-2506-2020
2. 4 Jun 2020 Recall initiated FDA recalls Z-2505-2020
3. 17 Jun 2025 Recall initiated FDA recalls Z-2127-2025
4. 17 Jun 2025 Recall initiated FDA recalls Z-2128-2025
5. 18 Jun 2025 Recall initiated FDA recalls Z-2168-2025
6. 18 Jun 2025 Recall initiated FDA recalls Z-2169-2025
7. 24 Sep 2026 Recall initiated FDA recalls Z-0303-2027
8. 24 Sep 2026 Recall initiated FDA recalls Z-0304-2027
9. 24 Sep 2026 Recall initiated FDA recalls Z-0302-2027
10. 6 Nov 2026 Registered EUDAMED B-00643169763401

6 earlier events are in the sections above.

Trade name

CareLink Encore™

Generic name

Cardiac pulse generator programmer

Device name

Programming Head

Model / reference

26901

Primary DI / UDI-DI

00643169763401 EUDAMED

00613994909565 GUDID

Basic UDI-DI

B-00643169763401

PMA number

P890003 ↗

FDA product code

OSR

EMDN code

J01900280 Implantable cardiac devices programmers - hardware accessory

GMDN term

Cardiac pulse generator programmer

Device class

Class AIMDD EUDAMED

Class III GUDID

EU registration type

Legacy device (under a directive)

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00643169763401; FDA GUDID lists 00613994909565), so their flags are not compared. Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Cardiac pulse generator programmer

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