FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
- Recall number
- Z-1796-2014
- Recalling firm
- Boston Scientific Corporation
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
- Status
- Terminated
- Initiated
- 2014-05-15
- Posted
- 2014-06-16
- Terminated
- 2015-06-25
- Reason
- Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
- Root cause
- Use error
- Action
- Customers were informed of the recall via overnight letter sent on May 15, 2014.
- Quantity
- 968 units total all models
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Catalog Number: PM4500N4; Material Number: M004PM45000N40; Serial numbers: 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, 16872124. Expiry Dates: May 11, 2014 to January 13, 2017
- 510(k) numbers
- not on file
- PMA numbers
- ["P020025S036"]
- Product code
- OAD
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28