FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
- Recall number
- Z-1191-2007
- Recalling firm
- Boston Scientific Corp
- Product
- Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
- Status
- Terminated
- Initiated
- 2007-06-26
- Posted
- 2007-08-22
- Terminated
- 2007-11-27
- Reason
- Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
- 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
- 30 units
- Distribution
- Product was distributed to 3 consignees in Florida and Tennessee.
- Lot, serial or model codes
- Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
- 510(k) numbers
- ["K924163"]
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 3001236349
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28