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

  • Model / Serial
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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