Boston Scientific Corp Chilli II Cooled Ablation Cathether, Model M00490310 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Chilli II Cooled Ablation Cathether, Model M00490310
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Batch Numbers: 804828 and 8048029
Products Sold
Batch Numbers: 804828 and 8048029
Boston Scientific Corp is recalling Chilli II Cooled Ablation Cathether, Model M00490310 due to Product is mislabeled with the incorrect catheter curve description.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is mislabeled with the incorrect catheter curve description.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026