Z-1191-2007

Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0

Name: Z-1191-2007 Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
Creator: Boston Scientific Corp
Published: 2007-06-26
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-06-26 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 on 2007-06-26. The reason FDA records is "Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes)". 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-1191-2007
Status: Terminated
Initiated: 2007-06-26
Posted: 2007-08-22
Terminated: 2007-11-27
Recalling firm: Boston Scientific Corporation
Product: Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it.
Quantity in commerce: 30 units
Distribution: Product was distributed to 3 consignees in Florida and Tennessee.
Product codes and lots: Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630

Product code DRF

K924163Class IIExplorer/360-Polaris-L.e./jackman Coron Sinus ElecBoston Scientific Corp / cleared 1993-09-03

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)