Devices

Device Recall Medstorm Adult Radiolucent LeadsOut Electrode

Model / Serial
Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. || Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
Manufacturer
Heart Sync, Inc
1 Event
- Recall of Device Recall Medstorm Adult Radiolucent LeadsOut Electrode

Manufacturer

Heart Sync, Inc

Manufacturer Address
Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
Manufacturer Parent Company (2017)
Heart Sync, 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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