Recall Z-0605-2024— Maquet Medical Systems USA

Name: FDA recall Z-0605-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-13

Class II · Ongoing

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2023-11-13. It names one FDA 510(k) clearance: K133598. Product: Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802. Reason: 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..

Recalling firm: Maquet Medical Systems USA
Classification: Class II
Status: Ongoing
Initiated: 2023-11-13
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133598 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2014-05-21

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

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.

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