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endomina platform

Endo Tools Therapeutics · Model endomina platform · UDI-DI 05425029282018

OCW Prescription

510(k) clearances

3,206

Adverse events (15 deaths)

Recalls

Facilities

Description

endomina platform primary packaging (x1)

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

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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.