Devices

Device Recall Boston Scientific TSX Transseptal Needle

Model / Serial
Lot Q823423, Exp 7/31/2018
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to one customer in the US.
Product Description
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; || Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Manufacturer
Merit Medical Systems, Inc.
1 Event
- Recall of Device Recall Boston Scientific TSX Transseptal Needle

Manufacturer

Merit Medical Systems, Inc.

Manufacturer Address
Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
Manufacturer Parent Company (2017)
Merit Medical Systems Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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