Boston Scientific RESONATE X4 CRT-D Model G447 Firmware Recall
Boston Scientific recalls RESONATE X4 CRT-D Model G447 devices with incorrect firmware configuration. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
The devices have an incorrect firmware configuration.
Contact the company
What happened, in plain English
Boston Scientific is recalling RESONATE X4 CRT-D devices with model number G447 due to an incorrect firmware configuration. This issue could lead to improper device function, though the recall does not specify immediate safety risks. Read more at govinfonow.com/recall/72906-boston-scientific-resonate-x4-crt-d-model-g447-firmware-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/72906-boston-scientific-resonate-x4-crt-d-model-g447-firmware-recall · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0081-2018
Cite this page
“Boston Scientific RESONATE X4 CRT-D Model G447 Firmware Recall.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72906-boston-scientific-resonate-x4-crt-d-model-g447-firmware-recall. Based on FDA recall #Z-0081-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2018%22&limit=1).
Why it’s dangerous
The devices have an incorrect firmware configuration that may cause improper device function. This could lead to potential issues with the device's performance but does not indicate a risk of serious injury or death in normal use.
Who’s affected
Medical device users who own or use the RESONATE X4 CRT-D Model G447 with the listed serial numbers. Patients receiving cardiac rhythm management therapy are most at risk.
How to tell if you have this one
Check if your device has the model number G447 and the specific serial numbers listed: 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606.
- Brand
Boston Scientific- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0077-2018 | RESONATE EL ICD VR, Model D432, Sterile.; Serial numbers 224020, 224209, 224322, 224366, and 224506 | 5 devices |
| Z-0078-2018 | RESONATE EL ICD DR, Model D433, Sterile.; Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767. | 12 devices |
| Z-0079-2018 | VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.; Serial numbers 174170, 174349, 174598, and 174606. | 4 devices |
| Z-0080-2018 | MOMENTUM X4 CRT-D, Model G138, Sterile.; Serial numbers 377292, 377337, 377341, and 377347 | 4 devices |
| Z-0081-2018 | RESONATE X4 CRT-D, Model G447, Sterile.; Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606 | 11 devices |
What to do — step by step
Check Device Serial Number
Verify your device's serial number against the list of affected numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in Minnesota and Ohio.
FDA distribution: “The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Minnesota, Ohio.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0081-2018 (October 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0081-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.