Instrument Command Library 2691

• FDA PMA P890003 decided 12 Aug 1998 Active
• FDA GUDID UDI-DI 00763000378356 listed 4 May 2024 Listed

• 3 recalls, same reason

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

  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
  • Ongoing Z-2169-2025 FDA Class II ·initiated 18 Jun 2025

  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
  • 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
  • Terminated Z-0400-2018 FDA Class II ·initiated 14 Jul 2017

  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

  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. 4 May 2024 Listed FDA GUDID 00763000378356
4. 17 Jun 2025 Recall initiated FDA recalls Z-2127-2025
5. 17 Jun 2025 Recall initiated FDA recalls Z-2128-2025
6. 18 Jun 2025 Recall initiated FDA recalls Z-2168-2025
7. 18 Jun 2025 Recall initiated FDA recalls Z-2169-2025
8. 24 Sep 2026 Recall initiated FDA recalls Z-0303-2027
9. 24 Sep 2026 Recall initiated FDA recalls Z-0304-2027
10. 24 Sep 2026 Recall initiated FDA recalls Z-0302-2027

5 earlier events are in the sections above.

Trade name

Instrument Command Library

Generic name

Implantable cardiac device management application software

Model / reference

2691

Primary DI / UDI-DI

00763000378356

PMA number

P890003 ↗

FDA product code

NVZ, OSR

GMDN term

Implantable cardiac device management application software

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: Implantable cardiac device management application software

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