IntellaTip MiFi XP Temperature Ablation Catheter — Class II medical device recall Z-1798-2014
Terminated recall by Boston Scientific Corporation, reported 2014-06-25, distributed nationwide. Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specificat
| Recall number | Z-1798-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Fremont, CA, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2014-06-16 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 968 units |
| Serial numbers | 16739673, 16739674, 16739675, 16739676, 16739677, 16739678, 16739679, 16739860, 16872121, 16872935 |
| Model numbers | PM4790K2 |
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Reason for recall
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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-1798-2014. 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.