Skip to content

SJM MRI Activator™ EX4000

by St. Jude Medical, Inc.

SJM MRI Activator™ EX4000 is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P140033 on 31 Jan 2017 and listed in FDA GUDID since 7 Feb 2017 (UDI-DI 05414734503648), active as of 23 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

5 ongoing

Recall on shared PMA P140033; other models may be affected

Documents

PMA P140033

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 Number05414734503648 UDI-DI Date7 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP140033 Date31 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P140033 decided 31 Jan 2017 Active
  • FDA GUDID UDI-DI 05414734503648 listed 7 Feb 2017 Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1497-2022 FDA Class II initiated 17 Jun 2022 on shared PMA P140033
    • Ongoing Z-1496-2022 FDA Class II initiated 17 Jun 2022 on shared PMA P140033

    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 on shared PMA P140033

    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.

  • 2 recalls, same reason

    • Ongoing Z-1530-2021 FDA Class I initiated 15 Mar 2021 on shared PMA P140033
    • Ongoing Z-1531-2021 FDA Class I initiated 15 Mar 2021 on shared PMA P140033

    Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

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

Timeline

7 dated events

  1. Approved FDA PMA P140033
  2. Listed FDA GUDID 05414734503648
  3. Recall initiated FDA recalls Z-1530-2021
  4. Recall initiated FDA recalls Z-1531-2021
  5. Recall initiated FDA recalls Z-1497-2022
  6. Recall initiated FDA recalls Z-1496-2022
  7. Recall initiated FDA recalls Z-1495-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
SJM MRI Activator™
Generic name
Multiple active implantable device programmer
Model / Ref / Catalog
EX4000
Primary DI / UDI-DI
05414734503648
PMA number
FDA product code
LWP
GMDN term
Multiple active implantable device programmer
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (P140033)

and 6 more cleared under P140033

Similar devices

Also classified as Multiple active implantable device programmer.

Similar devices in this category

Other devices filed under Multiple active implantable device programmer.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Prescription use
  • Serial number
  • Expiration date
Other properties (12, all answered No)