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Propeller

RECIPROCAL LABS CORPORATION · Model Sensor Model 2014-D · UDI-DI 00865528000037

CAF

510(k) clearances

3,267

Adverse events (43 deaths)

Recalls

191

Facilities

Description

The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers. When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique. When used under the care of a physician with a prescribed DPI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from Child (>2 years) to adult. The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.

Recalls

Date	Firm	Reason
2023-08-04	MEDLINE INDUSTRIES, LP - Northfield	Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
2021-03-31	Smiths Medical ASD Inc.	The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
2018-08-29	SANRAI INTERNATIONAL LLC	The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
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.
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.
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.
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.
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.
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.
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.

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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.