Devices

Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

Model / Serial
Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
Product Description
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
Manufacturer
St Jude Medical CRMD
1 Event
- Recall of Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

Manufacturer

St Jude Medical CRMD

Manufacturer Address
St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
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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