IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open… — Class III medical device recall Z-0700-2019
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-0700-2019 |
|---|---|
| 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 | 20368736, 20371559, 20371742, 20463744, 20531648, 20542305, 20548241, 20560477, 20566637, 20622763, 20628704, 20628705, 20639975, 20677314, 20763900, 20769113, 20772834, 20775597, 21318000, 21318001, 21357647, 21463186, 21543193, 21574774, 22195929, 22202991, 22290601, 22305067, 22315782, 22317356, 22321772, 22326857, 22327178, 22329367, 22330626, 22340824, 22371866, 22371868, 22371871, 22374909 and 6 more |
| Expiration dates | 2020-03-05, 2020-03-06, 2020-03-08, 2020-03-28, 2020-04-16, 2020-04-18, 2020-04-19, 2020-04-23, 2020-04-24, 2020-05-08, 2020-05-09, 2020-05-10, 2020-05-14, 2020-05-21, 2020-06-12, 2020-06-13, 2020-06-14, 2020-10-29, 2020-11-10, 2020-12-03, 2020-12-20, 2021-01-04, 2021-05-31, 2021-06-03, 2021-06-25 and 13 more |
Product
IntellaTip 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-0700-2019. 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.