Accolade MRI Pacemaker

Boston Scientific

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Sign in to save implants to your account

For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

1/1/2024 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

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.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

9/9/2018 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

6/2/2021 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

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).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

12/6/2017 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

No 510(k) clearance data available for this device.

⚠️8 Active Recalls

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Cardiac Pacemakers

Body Region

Heart/Chest

MRI Conditions

MR Conditional at 1.5T and 3T with ImageReady system. ENDURALIFE battery technology.

Post-MRI Notes

Interrogate device and exit MRI Protection mode.

Tracked Settings

012345678910111213141516171819202122232425262728293031323334353637383940414243444546474849505152
🔔 Get Recall Alerts for Accolade MRI Pacemaker
Get notified if the FDA issues a recall for this specific implant

Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.