Z-0473-06

Chilli II Cooled Ablation Cathether, Model M00490310

Name: Z-0473-06 Chilli II Cooled Ablation Cathether, Model M00490310
Creator: Boston Scientific Corp
Published: 2005-12-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-12-30 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Chilli II Cooled Ablation Cathether, Model M00490310 on 2005-12-30. The reason FDA records is "Product is mislabeled with the incorrect catheter curve description". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0473-06
Status: Terminated
Initiated: 2005-12-30
Posted: 2006-02-04
Terminated: 2006-08-24
Recalling firm: Boston Scientific Corporation
Product: Chilli II Cooled Ablation Cathether, Model M00490310
Product code: LPD
Reason for recall: Product is mislabeled with the incorrect catheter curve description.
Root cause tag: labeling and UDI
FDA 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 in commerce: 35 units
Distribution: Product was released for distribution to 14 consignees in US.
Product codes and lots: Batch Numbers: 804828 and 8048029

Product code LPD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)