Home / Recalls / Maquet Medical Systems USA / Z-0605-2024

Z-0605-2024 Class II Ongoing

Recalled by Maquet Medical Systems USA — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
November 13, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1213 US, 2589 OUS

Product Description

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

Reason for Recall

Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.

Distribution Pattern

Domestic distribution Nationwide. Foreign distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Canada, Cayman Islands, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Islamic Republic Of Iraq, Italy, Japan, Kazakhstan, Korea, Republic Of Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

Code Information

UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927

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-0555-2024 Class II — CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide r (November 6, 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)