Recall Z-0211-2015— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0211-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-17

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2014-10-17, terminated 2016-04-06. It names one FDA 510(k) clearance: K102726. Product: Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).. Reason: Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power.

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Terminated: 2016-04-06
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102726 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2011-04-04

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 System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

Reason for recall

Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power

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