Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
This recall has been terminated (originally issued August 22, 2007).
- Company
- Boston Scientific Corp
- Recall Initiated
- June 26, 2007
- Posted
- August 22, 2007
- Terminated
- November 27, 2007
- Recall Number
- Z-1191-2007
- Quantity
- 30 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
Distribution
Product was distributed to 3 consignees in Florida and Tennessee.
Lot / Code Info
Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
Root Cause
Labeling mix-ups
Action Taken
The firm issued notification letters to its consignees, sent 06/26/2007, via FedEx. The firm intends to remove the product and destroy it.
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