FDA Medical Device Recalls (openFDA)
Boston Scientific: Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
- Recall number
- Z-0639-05
- Recalling firm
- Boston Scientific
- Product
- Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
- Status
- Terminated
- Initiated
- 2005-02-14
- Posted
- 2005-03-18
- Terminated
- 2005-08-22
- Reason
- The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
- Root cause
- Other
- Action
- All consignees were notified via customer letters sent out on 02/14/2005. Distributors outside the US will be formally notified via the firm's recall procedures.
- Quantity
- 6694 units were distributed.
- Distribution
- This product was distributed to 521 accounts worldwide.
- Lot, serial or model codes
- Model numbers 8031, 8038, 8048, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0. Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
- 510(k) numbers
- ["K000277","K003782","K021232","K983171","K992777"]
- PMA numbers
- not on file
- Product code
- MTD
- 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