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Terminated

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

FDA Recall Z-1191-2007 · Posted 2007-08-22

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeDRF
Date Initiated2007-06-26
Date Terminated2007-11-27
Product Quantity30 units

Reason for Recall

Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was distributed to 3 consignees in Florida and Tennessee.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELECBoston Scientific Corp · 1993-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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