Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
FDA device recall Z-1191-2007 · posted 2007-08-22 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 30 units
- Distribution
- Product was distributed to 3 consignees in Florida and Tennessee.
- Date initiated
- 2007-06-26
- Date posted
- 2007-08-22
- Date terminated
- 2007-11-27
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC (K924163) | Boston Scientific Corp | 1993-09-03 |