Boston Scientific Corp: Medical Device Recall in 2015 - (Recall #: Z-1209-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: February 3, 2015

Date Posted: March 11, 2015

Recall Number: Z-1209-2015

Event ID: 70506

Reason for Recall:

Reports of formation of char adherent to the proximal part of the distal tip electrodes

Status: Terminated

Product Quantity: 14 units

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.

Distribution Pattern:

Distributed in Germany, Great Britain, and the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated