IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620
FDA device recall Z-1209-2015 · posted 2015-03-02 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Reports of formation of char adherent to the proximal part of the distal tip electrodes
- Action taken
- Customer notification letters were sent by overnight mail on February 10, 2015.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OAD
- Quantity affected
- 14 units
- Distribution
- Distributed in Germany, Great Britain, and the Netherlands.
- Date initiated
- 2015-02-03
- Date posted
- 2015-03-02
- Date terminated
- 2017-03-21
- Location
- San Jose, CA
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