Boston Scientific Corp Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
Products Sold
Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
Boston Scientific Corp is recalling Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 due to Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
Recommended Action
Per FDA guidance
The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it.
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
FL, IN, TN
Page updated: Jan 10, 2026