CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
Resonate X4 Crt-d recalled by Boston Scientific
Boston Scientific is recalling Resonate X4 Crt-d, distributed in Minnesota, Ohio. The recall was initiated on 4 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0081-2018
- FDA event ID
- 78323
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Oct 2017
- FDA classified
- 8 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Oct 2017 | Recall initiated by company | |
| 8 Nov 2017 | Classified by FDA | +35 days |
| 15 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices have an incorrect firmware configuration.
Product as listed by the FDA
RESONATE X4 CRT-D, Model G447, Sterile.
Where it was distributed
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Questions about this recall
Why was it recalled?
The devices have an incorrect firmware configuration.
Which lots are affected?
Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606
Where was it sold?
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 78323| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Resonate El Icd Vr recalled by Boston Scientific | Boston Scientific | Other | MN, OH | |
| CLASS II | Momentum X4 Crt-d recalled by Boston Scientific | Boston Scientific | Other | MN, OH | |
| CLASS II | Resonate El Icd Dr recalled by Boston Scientific | Boston Scientific | Other | MN, OH | |
| CLASS II | Vigilant X4 Crt-d recalled by Boston Scientific | Boston Scientific | Device Malfunction | MN, OH |
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