Z-0639-05

Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075

Name: Z-0639-05 Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
Creator: Boston Scientific
Published: 2005-02-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-02-14 / Terminated

FDA source

Boston Scientific began a recall of Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 on 2005-02-14. The reason FDA records is "The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0639-05
Status: Terminated
Initiated: 2005-02-14
Posted: 2005-03-18
Terminated: 2005-08-22
Recalling firm: Boston Scientific Corporation
Product: Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
Product code: MTD Catheter, Intracardiac Mapping, High-Density Array
Reason for recall: The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
FDA 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 in commerce: 6694 units were distributed.
Distribution: This product was distributed to 521 accounts worldwide.
Product codes and lots: 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.

Product code MTD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)