Home / Recalls / Boston Scientific Corp / Z-1209-2015

Z-1209-2015 Class I Terminated

Recalled by Boston Scientific Corp — San Jose, CA

Recall Details

Product Type
Devices
Report Date
March 11, 2015
Initiation Date
February 3, 2015
Termination Date
March 21, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units

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

Distribution Pattern

Distributed in Germany, Great Britain, and the Netherlands.

Code Information

Material number: M004EPM96200, Catalog Number EPM9620; Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879. Material number: M004EPM9620K20, Catalog Number: EPM9620K2: Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714. Material number : M004EPM9620N40; Catalog number: EPM9620N4; Serial numbers: 17148152, 17226126, 17266642. All with Expiry Dates of April 20, 2015 - June 14, 2015.

Other recalls by Boston Scientific Corp

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  • Z-1735-2020 Class II — Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 ( (March 9, 2020)
  • Z-1737-2020 Class II — Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 (March 9, 2020)
  • Z-1731-2020 Class II — Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00667 (March 9, 2020)
  • Z-1738-2020 Class II — Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 (March 9, 2020)