Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software
Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ICD) where the hazard is the use of unapproved software, but the source text does not report any illnesses, injuries, or deaths, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Boston Scientific Corporation is recalling one unit of the DYNAGEN EL ICD DR, Model D152, implantable cardioverter defibrillator. The recall is limited to the device with Serial Number 516959, which was distributed in North Carolina, Tennessee, and Missouri.
The recall was initiated because Boston Scientific released a new Software Update Application that was downloaded to four Model 3300 programmers. This application directed the programmers to download software applications that have not been approved by the US Food and Drug Administration.
Patients with this specific device should contact their healthcare provider or Boston Scientific for further instructions regarding the software status of their device.
The recalled product
- Product
- 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…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 516959
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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