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229047

by Medtronic, Inc.

Ref 229047

229047 is a device classified as Active implantable (AIMDD) (EU), Class III (US) made by Medtronic, Inc., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-00721902256011), approved under FDA PMA P890003 on 12 Aug 1998 and listed in FDA GUDID since 23 Sep 2014 (UDI-DI 00721902256011), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE AIMDD PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

9 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P890003

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00721902256011 Basic UDI-DI 00721902256011UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00721902256011 UDI-DI Date23 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP890003 Date12 Aug 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00721902256011 registered 14 Aug 2026 Active
  • FDA PMA P890003 decided 12 Aug 1998 Active
  • FDA GUDID UDI-DI 00721902256011 listed 23 Sep 2014 Listed

Recalls

13 recalls · 9 ongoing · FDA

  • 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
    • Ongoing Z-2128-2025 FDA Class II initiated 17 Jun 2025

    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.

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-2506-2020
  2. Recall initiated FDA recalls Z-2505-2020
  3. Recall initiated FDA recalls Z-2127-2025
  4. Recall initiated FDA recalls Z-2128-2025
  5. Recall initiated FDA recalls Z-2168-2025
  6. Recall initiated FDA recalls Z-2169-2025
  7. Registered EUDAMED B-00721902256011
  8. Recall initiated FDA recalls Z-0303-2027
  9. Recall initiated FDA recalls Z-0304-2027
  10. Recall initiated FDA recalls Z-0302-2027

6 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Generic name
Implantable pacemaker analyser, intraoperative
Device name
CareLink Pacing System Analyzer
Model / reference
229047
Primary DI / UDI-DI
00721902256011
Basic UDI-DI
B-00721902256011
PMA number
FDA product code
OSR, KRG
EMDN code
J01900203 Implantable cardiac devices programmers
GMDN term
Implantable pacemaker analyser, intraoperative
Device class
Class AIMDD EUDAMED
Class III GUDID
Regulation number
870.3700
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class AIMDD
GUDID
Class III
ImplantableEUDAMED
Yes
GUDID
No

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.

Related devices

Category: Implantable pacemaker analyser, intraoperative

Cleared under the same submission (P890003)

and 8 more cleared under P890003

Similar devices in this category

Other devices filed under IMPLANTABLE CARDIAC DEVICES - VARIOUS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Serial number
Other properties (22, all answered No)