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De Soutter Medical

DE SOUTTER MEDICAL LIMITED · Model P20-107 · UDI-DI 05051471123700

FQH Prescription

510(k) clearances

4,888

Adverse events (5 deaths)

Recalls

140

Facilities

Description

ECO PULSE - H/P HIP ARTHROPLASTY PUMP KIT WITH SUCTION

Recalls

Date	Firm	Reason
2024-03-19	Medtronic Perfusion Systems	Potential for unsealed sterile packing.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2019-08-16	IrriMAX Corporation	Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
2019-01-24	Maquet Cardiovascular, LLC	Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2015-05-08	Stryker Instruments Div. of Stryker Corporation	Potential sterility breach in the packaging.
2015-02-11	EXP Pharmaceutical Services Corp	EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re
2010-10-04	Stryker Instruments Division of Stryker Corporation	There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
2010-10-04	Stryker Instruments Division of Stryker Corporation	There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.

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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.