Home › Endo Tools Therapeutics › endomina system

endomina system

Endo Tools Therapeutics · Model endomina system · UDI-DI 05425029282070

OCW Prescription

510(k) clearances

3,286

Adverse events (15 deaths)

Recalls

Facilities

Description

endomina system is composed of 1 endomina platform and 6 TAPES

Recalls

Date	Firm	Reason
2026-07-14	Boston Scientific Corporation	Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-07-14	Boston Scientific Corporation	Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
2026-04-15	Covidien, LP	The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
2023-11-16	Covidien LP	Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product steril

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.