Home / Recalls / Maquet Medical Systems USA / Z-0555-2024

Z-0555-2024 Class II Ongoing

Recalled by Maquet Medical Systems USA — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
December 20, 2023
Initiation Date
November 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1595 units

Product Description

CARDIOHELP-i Heart Lung Support System- 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 Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)

Reason for Recall

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, R¿union, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Code Information

UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.

Other recalls by Maquet Medical Systems USA

  • Z-1831-2024 Class II — CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. (April 15, 2024)
  • Z-1077-2024 Class II — BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. U (January 16, 2024)
  • Z-1076-2024 Class II — Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 7010 (January 16, 2024)
  • Z-0978-2024 Class II — BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70104 (January 8, 2024)
  • Z-0977-2024 Class II — BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70104 (January 8, 2024)
  • Z-1053-2024 Class II — Bubble Sensor (REF: 70105.5720) (December 28, 2023)
  • Z-0595-2024 Class III — CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide rem (November 14, 2023)
  • Z-0605-2024 Class II — Venous probe connection cable (REF 701069333 and 701048804) used with the Cardio (November 13, 2023)
  • Z-0290-2024 Class II — Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers (October 12, 2023)
  • Z-0420-2024 Class I — CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP (October 10, 2023)