Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075
This recall has been terminated (originally issued March 18, 2005).
- Company
- Boston Scientific
- Recall Initiated
- February 14, 2005
- Posted
- March 18, 2005
- Terminated
- August 22, 2005
- Recall Number
- Z-0639-05
- Quantity
- 6694 units were distributed.
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
Distribution
This product was distributed to 521 accounts worldwide.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.