Recall Z-1209-2015— Boston Scientific Corp
Class I · Terminated
Class I FDA medical device recall by Boston Scientific Corp, initiated 2015-02-03, terminated 2017-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.. Reason: Reports of formation of char adherent to the proximal part of the distal tip electrodes.
- Recalling firm
- Boston Scientific Corp
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-02-03
- Terminated
- 2017-03-21
- Firm location
- San Jose, CA, United States
Product description
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US.
Reason for recall
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Data sourced from openFDA. This site is unofficial and independent of the FDA.