Recalls / —
—#169714
Product
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 product code
- OAD — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P150005S008
- Affected lot / code info
- IntellaNav Open-Irrigated Ablation Catheter Material Number: M004R96200 Batch: 22208397 Expiration Date: 6/4/2021 Batch: 22389516 Expiration Date: 7/16/2021 Batch: 22525798 Expiration Date: 2/14/2020
Why it was recalled
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291
Distribution
- Distribution pattern
- Japan
Timeline
- Recall initiated
- 2018-11-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #169714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.