CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
Implantable Cardioverter Defibrillator, Dynagen EL ICD DR recalled
Boston Scientific is recalling Boston Scientific, Implantable Cardioverter Defibrillator, Dynagen EL ICD DR, distributed nationwide in the US. The recall was initiated on 12 Feb 2020 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-1512-2020
- FDA event ID
- 85077
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2020
- FDA classified
- 18 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 12 Feb 2020 | Recall initiated by company | |
| 18 Mar 2020 | Classified by FDA | +35 days |
| 25 Mar 2020 | 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
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Where it was distributed
US Nationwide distribution in the states of NC, TN, and MO.
Questions about this recall
Is Implantable Cardioverter Defibrillator, Dynagen EL ICD DR recalled?
Yes. Boston Scientific recalled Implantable Cardioverter Defibrillator, Dynagen EL ICD DR on 12 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1512-2020.
Why was it recalled?
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Which lots are affected?
Serial Number 516959
Where was it sold?
US Nationwide distribution in the states of NC, TN, and MO.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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