Home › Device types › DTQ
Console, Heart-Lung Machine, Cardiopulmonary Bypass
FDA product code DTQ · Class 2 · Cardiovascular
336
Registered devices
17,564
Adverse events
267
Recalls
52
510(k) clearances
Devices with this code
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationQuantum — SPECTRUM MEDICAL LIMITEDQuantum — SPECTRUM MEDICAL LIMITEDMAQUET CARDIOHELP — Maquet Cardiopulmonary AGQuantum — SPECTRUM MEDICAL LIMITEDESSENZ — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationVenous Line Clamp — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationS5 Shelf with AC Outlet Strip — LivaNova Deutschland GmbHQuantum — SPECTRUM MEDICAL LIMITEDTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationS5 Shelf without AC Outlet Strip — LivaNova Deutschland GmbHMAQUET CARDIOHELP — Maquet Cardiopulmonary AGInterface — LivaNova Deutschland GmbHAccessories — LivaNova Deutschland GmbHTerumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems CorporationB-Care5 — LivaNova Deutschland GmbHSCPC — LivaNova Deutschland GmbHLevel Control — LivaNova Deutschland GmbHQuantum — SPECTRUM MEDICAL LIMITEDQuantum — SPECTRUM MEDICAL LIMITEDQuantum — SPECTRUM MEDICAL LIMITEDESSENZ — 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 |
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