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Verity™ ADx XL VDR

by St. Jude Medical, Inc. 2 variants

Verity™ ADx XL VDR (5456) is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P880086 on 21 Aug 1989 and listed in FDA GUDID since 3 Feb 2017 (UDI-DI 05414734006910), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P880086

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734006910 UDI-DI Date3 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP880086 Date21 Aug 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P880086 decided 21 Aug 1989 Active
  • FDA GUDID UDI-DI 05414734006910 listed 3 Feb 2017 Listed

Recalls

9 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1496-2022 FDA Class II initiated 17 Jun 2022
    • Ongoing Z-1497-2022 FDA Class II initiated 17 Jun 2022

    The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

    • Ongoing Z-1495-2022 FDA Class II initiated 17 Jun 2022

    There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

    • Terminated Z-0430-2012 FDA Unclassified (pre-2012) initiated 23 Sep 2011

    St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

    • Terminated Z-0429-2012 FDA Unclassified (pre-2012) initiated 23 Sep 2011

    St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

  • 3 recalls, same reason

    • Terminated Z-0298-2007 FDA Unclassified (pre-2012) initiated 6 Oct 2006
    • Terminated Z-0296-2007 FDA Unclassified (pre-2012) initiated 6 Oct 2006 on shared PMA P880086
    • Terminated Z-0297-2007 FDA Unclassified (pre-2012) initiated 6 Oct 2006 on shared PMA P880086

    St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

    • Terminated Z-0052-04 FDA Unclassified (pre-2012) initiated 31 Jul 2003

    Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-0052-04
  2. Recall initiated FDA recalls Z-0298-2007
  3. Recall initiated FDA recalls Z-0296-2007
  4. Recall initiated FDA recalls Z-0297-2007
  5. Recall initiated FDA recalls Z-0430-2012
  6. Recall initiated FDA recalls Z-0429-2012
  7. Listed FDA GUDID 05414734006910
  8. Recall initiated FDA recalls Z-1496-2022
  9. Recall initiated FDA recalls Z-1497-2022
  10. Recall initiated FDA recalls Z-1495-2022

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Specification

GUDID

Trade name
Verity™
Generic name
Dual-chamber implantable pacemaker, rate-responsive
Model / Ref / Catalog
ADx XL VDR, 5456
Primary DI / UDI-DI
05414734006910
PMA number
FDA product code
DXY
GMDN term
Dual-chamber implantable pacemaker, rate-responsive
Device class
Class III
Regulation number
870.3610
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 11 Milliliter

Related devices

Category: Dual-chamber implantable pacemaker, rate-responsive

Cleared under the same submission (P880086)

and 8 more cleared under P880086

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)