Home › Device types › DTQ
Console, Heart-Lung Machine, Cardiopulmonary Bypass
FDA product code DTQ · Class 2 · Cardiovascular
335
Registered devices
17,288
Adverse events
267
Recalls
52
510(k) clearances
Devices with this code
S5 Mast Roller Pump — LivaNova Deutschland GmbHSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDS5 Double Roller Pump 85 — LivaNova Deutschland GmbHQuantum — SPECTRUM MEDICAL LIMITEDAccessories — LivaNova Deutschland GmbHQuantum — SPECTRUM MEDICAL LIMITEDTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationESSENZ — LivaNova Deutschland GmbHVariolock — LivaNova Deutschland GmbHS5 Roller Pump 150 — LivaNova Deutschland GmbHConsole Lamp — LivaNova Deutschland GmbHESSENZ — LivaNova Deutschland GmbHESSENZ — LivaNova Deutschland GmbHESSENZ — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationVariolock — LivaNova Deutschland GmbHC5 — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationNA — Maquet Cardiopulmonary AGVariolock — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationVenous Line Clamp — LivaNova Deutschland GmbHVariolock — LivaNova Deutschland GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-09 | Maquet Cardiopulmonary Gmbh | Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending |
| 2025-04-30 | Maquet Cardiopulmonary Ag | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. |
| 2024-10-18 | LivaNova Deutschland GmbH | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backu |
| 2024-04-15 | Maquet Medical Systems USA | The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. |
| 2023-12-28 | Maquet Medical Systems USA | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the l |
| 2023-11-14 | Maquet Medical Systems USA | CARDIOHELP-i System was not properly tested to measure leakage current |
| 2023-11-13 | Maquet Medical Systems USA | Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence |
| 2023-11-06 | Maquet Medical Systems USA | Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the |
| 2023-10-12 | Maquet Medical Systems USA | It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt |
| 2023-10-10 | Maquet Medical Systems USA | Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.