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Open, Classified

IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

FDA Recall Z-0701-2019 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeOAD
Date Initiated2018-11-28
Product Quantity1,282 (all three types in Japan)

Reason for Recall

Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

Firm Action

On November 28, 2018, Boston Scientific sent Urgent Medical Device Removal - Immediate Action Required letters to their Japanese consignees requesting them to check and segregate any of the recalled product. The letter also asked the consignees to conduct sub-recalls, if necessary, and to return The Reply Verification Tracking Form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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