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Renasys

SMITH & NEPHEW MEDICAL LIMITED · Model 66020961 · UDI-DI 00040565127231

OMP

510(k) clearances

9,182

Adverse events (75 deaths)

Recalls

102

Facilities

Description

The RENASYS Procedure Packs are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Recalls

Date	Firm	Reason
2025-01-17	KCI USA, INC.	Due to increase in complaints related to leak alarms
2024-11-05	KCI USA, INC.	Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
2024-10-02	Smith & Nephew Medical, Ltd.	Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
2024-03-11	Smith & Nephew Medical, Ltd.	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
2024-03-11	Smith & Nephew Medical, Ltd.	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
2020-06-08	KCI USA, INC.	The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
2020-06-04	Cardinal Health 200, LLC	Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
2020-06-04	Cardinal Health 200, LLC	Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
2019-12-02	Medela Inc	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
2018-02-07	Medela Inc	Device may display a battery missing error.

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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.