Recall Z-0420-2024— Maquet Medical Systems USA

Name: FDA recall Z-0420-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-10

Class I · Ongoing

Class I FDA medical device recall by Maquet Medical Systems USA, initiated 2023-10-10. It names one FDA 510(k) clearance: K133598. Product: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.. Reason: 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 blood flow. Potential associated harms are ischemia and hypoxia..

Recalling firm: Maquet Medical Systems USA
Classification: Class I
Status: Ongoing
Initiated: 2023-10-10
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133598 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2014-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Reason for recall

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 blood flow. Potential associated harms are ischemia and hypoxia.

Data sourced from openFDA. This site is unofficial and independent of the FDA.