Boston Scientific Recalls 12 Resonate EL ICD Devices for Firmware Error
Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
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) with a functional defect (incorrect firmware), which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 12 units of the Resonate EL ICD DR, Model D433, sterile implantable cardioverter-defibrillators. The recall is being conducted because the devices have an incorrect firmware configuration.
The affected devices were distributed to medical facilities located in Minnesota and Ohio. There was no foreign, government, or military distribution. The specific serial numbers involved are 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.
Patients who have received these devices should contact their healthcare provider for further instructions regarding the recall and any necessary follow-up care.
The recalled product
- Product
- RESONATE EL ICD DR, Model D433, Sterile.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 12
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 (12)
- Serial numbers 530802
- 531123
- 531237
- 531292
- 531301
- 531446
- 531492
- 531520
- 531536
- 531539
- 531545
- and 531767.
Distribution
Part of a larger recall action
This product is one of 5 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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