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SIMPULSE

Davol Inc. · Model 0057590 · UDI-DI 00801741065262

FQH Prescription

510(k) clearances

4,888

Adverse events (5 deaths)

Recalls

140

Facilities

Description

Simpulse Plus System with Soft Splash Shield Tip, Suction Tubing, and Dual Spike Adapter

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.