NaviAid™ AB
SMART MEDICAL SYSTEMS LTD · Model AB-R · UDI-DI 07290018671634
Description
Device Description (max 2000 characters): The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestine while utilizing the existing endoscope optics and utilities. The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through the instrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloon air supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of the balloon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | Boston Scientific Corporation | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button |
| 2026-02-12 | Olympus Corporation of the Americas | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
| 2026-02-12 | Olympus Corporation of the Americas | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. |
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