Recall Z-0595-2024— Maquet Medical Systems USA

Name: FDA recall Z-0595-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-14

Class III · Ongoing

Class III FDA medical device recall by Maquet Medical Systems USA, initiated 2023-11-14. It names one FDA 510(k) clearance: K133598. Product: CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012. Reason: CARDIOHELP-i System was not properly tested to measure leakage current.

Recalling firm: Maquet Medical Systems USA
Classification: Class III
Status: Ongoing
Initiated: 2023-11-14
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-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012

Reason for recall

CARDIOHELP-i System was not properly tested to measure leakage current

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