# FDA recall Z-0605-2024

> **Maquet Medical Systems USA** · Class II · device recall initiated 2023-11-13.

## Product

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

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.

## Key facts

- **Recall number:** Z-0605-2024
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-13
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0605-2024

## Citation

> AI Analytics. FDA recall Z-0605-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0605-2024. Source: US FDA. Licensed CC0.

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