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CoroFlow Cardiovascular System
COROVENTIS Research AB · Model 12000WW · UDI-DI 07350111070038
DQK
Prescription
1
510(k) clearances
4,492
Adverse events (53 deaths)
125
Recalls
179
Facilities
Description
CoroFlow Cardiovascular System is a system used to collect, calculate, present and store physiological parameters measured by Abbott Medical’s PressureWire X and Wi-box. Parameters include Pa, Pd, FFR, Pd/Pa, RFR, CFR, IMR, RRR, Absolute Flow, Absolute Resistance, dP/dt, PPG, intravascular temperature. CoroFlow Cardiovascular System is installed on a personal computer and receives measurement data wirelessly via the CoroHub Receiver. Information is displayed on the computers screen which can optionally be slaved to a monitor inside the coronary cathlab.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | GE Medical Systems Information Technologies Inc | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. |
| 2026-04-24 | GE Medical Systems Information Technologies Inc | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charr |
| 2025-09-16 | Spacelabs Healthcare, Ltd. | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm |
| 2025-08-11 | Merge Healthcare, Inc. | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes |
| 2025-04-11 | Centerline Biomedical Inc | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
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Get your free API keyRead the docsData 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.