FDA Recall
Terminated
RESONATE EL ICD DR, Model D433, Sterile.
Recall: Z-0078-2018
·
Initiated October 4, 2017
Recall
- Recall Number
- Z-0078-2018
- Event Number
- 78323
- Firm
- Boston Scientific Corporation
- FEI Number
- 2124215
- Product Code
- LWS
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 4, 2017
- Terminated
- October 15, 2019
- Address
- 4100 Hamline Ave N, Saint Paul, MN, 55112-5700
Description
RESONATE EL ICD DR, Model D433, Sterile.
Reason
The devices have an incorrect firmware configuration.
Action
The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.
Distribution
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Quantity
12 devices