Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2020 - (Recall #: Z-0632-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

Product Classification:

Class II

Date Initiated: November 20, 2020

Date Posted: December 23, 2020

Recall Number: Z-0632-2021

Event ID: 86796

Reason for Recall:

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Status: Terminated

Product Quantity: 58,438 devices worldwide

Code Information:

Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated