FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Chilli II Cooled Ablation Cathether, Model M00490310
- Recall number
- Z-0473-06
- Recalling firm
- Boston Scientific Corp
- Product
- Chilli II Cooled Ablation Cathether, Model M00490310
- Status
- Terminated
- Initiated
- 2005-12-30
- Posted
- 2006-02-04
- Terminated
- 2006-08-24
- Reason
- Product is mislabeled with the incorrect catheter curve description.
- Root cause
- Other
- Action
- On 12/30/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Quantity
- 35 units
- Distribution
- Product was released for distribution to 14 consignees in US.
- Lot, serial or model codes
- Batch Numbers: 804828 and 8048029
- 510(k) numbers
- not on file
- PMA numbers
- ["P980003"]
- Product code
- LPD
- Firm FEI
- 3001236349
- Firm city
- San Jose
- 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