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Amsel Occluder Device

AMSEL MEDICAL CORPORATION · Model 100-200 · UDI-DI 00857774006000

FZP Prescription

510(k) clearances

42,394

Adverse events (126 deaths)

Recalls

107

Facilities

Description

The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Recalls

Date	Firm	Reason
2023-04-28	TELEFLEX LLC	Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of th
2021-04-16	Aesculap Implant Systems LLC	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
2021-04-16	Aesculap Implant Systems LLC	Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
2020-09-17	Genicon, Inc.	Device malfunction causing the applier to jam, and clip loading failures.
2019-11-07	Ethicon Endo-Surgery Inc	A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
2019-10-04	Teleflex Medical	Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming
2019-10-04	Teleflex Medical	Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming
2018-04-02	AESDEX	Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
2018-04-02	AESDEX	Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.
2018-01-22	Aesculap Implant Systems LLC	Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.

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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.