Contak Renewal TR Pulse Generator

• • Ongoing Z-1771-2026 FDA Class I ·initiated 19 Mar 2026

  Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

• 5 recalls, same reason

  • Ongoing Z-0104-2026 FDA Class I ·initiated 20 Aug 2025
  • Ongoing Z-0101-2026 FDA Class I ·initiated 20 Aug 2025
  • Ongoing Z-0103-2026 FDA Class I ·initiated 20 Aug 2025
  • Ongoing Z-0105-2026 FDA Class I ·initiated 20 Aug 2025
  • Ongoing Z-0102-2026 FDA Class I ·initiated 20 Aug 2025

  Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

• 2 recalls, same reason

  • Ongoing Z-0827-2025 FDA Class I ·initiated 12 Dec 2024
  • Ongoing Z-0826-2025 FDA Class I ·initiated 12 Dec 2024

  A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

• 3 recalls, same reason

  • Ongoing Z-2019-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2020-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2018-2021 FDA Class I ·initiated 3 Jun 2021

  The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

• 2 recalls, same reason

  • Ongoing Z-2002-2021 FDA Class II ·initiated 3 Jun 2021
  • Ongoing Z-2003-2021 FDA Class II ·initiated 3 Jun 2021

  Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

• 4 recalls, same reason

  • Ongoing Z-0365-2018 FDA Class II ·initiated 7 Dec 2017
  • Ongoing Z-0360-2018 FDA Class II ·initiated 7 Dec 2017
  • Ongoing Z-0366-2018 FDA Class II ·initiated 7 Dec 2017
  • Ongoing Z-0361-2018 FDA Class II ·initiated 7 Dec 2017

  Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

• 2 recalls, same reason

  • Terminated Z-3258-2018 FDA Class II ·initiated 10 Sep 2018 ·on shared PMA P030005
  • Terminated Z-3259-2018 FDA Class II ·initiated 10 Sep 2018 ·on shared PMA P030005

  Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

• • Terminated Z-1298-06 FDA Unclassified (pre-2012) ·initiated 24 Jun 2006

  Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion without warning in the affected devices.

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

Full name

Contak Renewal Tr

Trade Name

Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software

Generic Name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

PMA Number

P030005 ↗

FDA Product Code

NKE

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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