Recall Z-0897-2022— Maquet Medical Systems USA

Name: FDA recall Z-0897-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-18

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2022-02-18. It names one FDA 510(k) clearance: K133598. Product: Cardiohelp-i Transport Guard with Transport Guard (701072525): is a 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 Code/REF Number: 701072780 (Cardiohelp-i). Reason: Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2022-02-18
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 Transport Guard with Transport Guard (701072525): is a 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 Code/REF Number: 701072780 (Cardiohelp-i)

Reason for recall

Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

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