FDA Device recall Z-1795-2014
IntellaTip MiFi XP Temperature Ablation Catheter
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of IntellaTip MiFi XP Temperature Ablation Catheter by Boston Scientific, citing some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1795-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-15 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm 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
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Identifiers
| code_info | Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16…Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1795-2014%22
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