Edwards Lifesciences, LLC: Medical Device Recall in 2018 - (Recall #: Z-0496-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

Product Classification:

Class II

Date Initiated: October 2, 2017

Date Posted: February 7, 2018

Recall Number: Z-0496-2018

Event ID: 78442

Reason for Recall:

Pre-procedural issues related to software defects

Status: Terminated

Product Quantity: 198 devices

Code Information:

HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 13800208, 13800210, 13800211, 13800126, 13800128, 13800129, 13800130, 13800132, 13800133, 13800135, 13800139, 13800140, 13800144, 13800146, 13800147, 13800148, 13800150, 13800187, 13800189, 13800131, 13800134, 13800136, 13800191, 13800192, 13800197, 13800172, 13800173, 13800159, 13800184, 13800188, 13800339, 13800355, 13800199, 13800200, 13800141, 13800249, 13800258, 13800259, 13800260, 13800263, 13800265, 13800268, 13800270, 13800176, 13800177, 13800179, 13800186, 13800225, 13800227, 13800230, 13800196, 13800124, 13800125, 13800137, 13800138, 13800142, 13800143, 13800145, 13800149, 13800151, 13800152); HEMSGM10 UDI 00690103196993 (Serial No. 13600223, 13600224, 13600225, 13600226, 13600257, 13600196, 13600197, 13600198, 13600227, 13600228, 13600229, 13600158, 13600159, 13600160, 13600161, 13600162, 13600163, 13600164, 13600165, 13600166, 13600167, 13600168, 13600169, 13600170, 13600171, 13600206, 13600207, 13600145, 13600146, 13600147, 13600208, 13600209, 13600211, 13600199, 13600201, 13600193, 13600194, 13600195, 13600390, 13600421, 13600212, 13600213, 13600202, 13600203, 13600204, 13600205, 13600255, 13600256, 13600258, 13600210, 13600148, 13600149, 13600150, 13600151 13600152, 13600153, 13600154, 13600155, 13600156, 13600157); HEMOXSC100 UDI 00690103196986 (Serial No. 13700241, 13700246, 13700247, 13700248, 13700303, 13700188, 13700189, 13700190, 13700280, 13700282, 13700291, 13700149, 13700150, 13700151, 13700152, 13700153, 13700154, 13700155, 13700156, 13700157, 13700158, 13700159, 13700160, 13700161, 13700162, 13700174, 13700177, 13700136, 13700137, 13700138, 13700179, 13700199, 13700182, 13700191, 13700192, 13700193, 13700194, 13700180, 13700185, 13700186, 13700183, 13700187, 13700201, 13700205, 13700215, 13700236, 13700240, 13700258, 13700265, 13700270, 13700271, 13700195, 13700196, 13700197, 13700198, 13700252, 13700301, 13700363, 13700175, 13700139, 13700140, 13700141, 13700142, 13700143, 13700144, 13700145, 13700146, 13700147, 13700148)

Distribution Pattern:

US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX

Voluntary or Mandated:

Voluntary: Firm initiated