Devices

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator

Model / Serial
S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution: USA including states of CA & FL
Product Description
St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator || The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
Manufacturer
Osypka Medical Inc
1 Event
- Recall of Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator

Manufacturer

Osypka Medical Inc

Manufacturer Address
Osypka Medical Inc, 7855 Ivanhoe Ave Ste 226, La Jolla CA 92037-4561
Manufacturer Parent Company (2017)
Osypka Medical 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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