IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open… — Class III medical device recall Z-0701-2019
Ongoing recall by Boston Scientific Corporation, reported 2019-01-16. Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in
| Recall number | Z-0701-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2018-11-28 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Countries outside the US | JP |
| Quantity | 1,282 |
| Reason classes | unapproved product |
| Lot numbers | 22208397, 22389516, 22525798 |
| Expiration dates | 2020-02-14, 2021-06-04, 2021-07-16 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0701-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.