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WECK

TELEFLEX INCORPORATED · Model IPN028150 · UDI-DI 34026704625032

FZP Prescription

510(k) clearances

42,203

Adverse events (126 deaths)

Recalls

108

Facilities

Description

HP TI SMALL 25 Clips/Cart

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.