NaviAid™ ABC
SMART MEDICAL SYSTEMS LTD · Model ABC · UDI-DI 07290018671658
Description
The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ ABC Device is comprised of a balloon catheter (‘ABC 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™ ABC 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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