Home › Device types › DPW
Flowmeter, Blood, Cardiovascular
FDA product code DPW · Class 2 · Cardiovascular
915
Registered devices
76
Adverse events
35
Recalls
138
510(k) clearances
Devices with this code
Medistim MiraQ Cardiac System — Medistim ASAMizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, box — VASCULAR TECHNOLOGY, INCORPORATEDMedistim VeriQCSystem — Medistim ASATransonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.VTI Power Cord: Hospital Europe — VASCULAR TECHNOLOGY, INCORPORATEDMedistim Interconnect Cable — Medistim ASATransonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.Capiox® Hardshell Reservoir — Terumo Cardiovascular Systems CorporationTransonic — TRANSONIC SYSTEMS INC.VTI 8 MHz TRANS-Q-TANEOUS Intraoperative Doppler Transceiver — VASCULAR TECHNOLOGY, INCORPORATEDTransonic — TRANSONIC SYSTEMS INC.DOPPLER MODEL 909 24V — PARKS MEDICAL ELECTRONICS, INC.PF 5010 LDPM Unit — Perimed ABTransonic — TRANSONIC SYSTEMS INC.Transonic — TRANSONIC SYSTEMS INC.DOPPLER MODEL 915-BL (UN) — PARKS MEDICAL ELECTRONICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-04 | Koven Technology, Inc. | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |
| 2025-09-26 | Medistim Asa | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to |
| 2025-08-07 | Flosonics Medical (R/A 1929803 ONTARIO CORP.) | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. |
| 2023-06-19 | Baxter Healthcare Corporation | An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery |
| 2018-06-19 | Vascular Technology, Inc. | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver |
| 2017-04-25 | Medistim Asa | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
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