Recall archive
61 recalls · page 1 of 3
Reported Jul 2, 2025
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature.…
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating…
FDA (openFDA device enforcement)
Reported Apr 10, 2024
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg,…
FDA (openFDA device enforcement)
Reported Apr 12, 2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand — Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up…
FDA (openFDA device enforcement)
Reported Jun 9, 2021
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
FDA (openFDA device enforcement)
Reported Dec 23, 2020
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand — Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
FDA (openFDA device enforcement)
Reported Sep 23, 2020
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2020
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 7, 2019
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control…
FDA (openFDA device enforcement)
Reported May 22, 2019
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Presence of natural rubber latex is not declared in the label
FDA (openFDA device enforcement)
Reported Oct 31, 2018
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not…
FDA (openFDA device enforcement)
Reported Oct 24, 2018
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — The service manual was not updated at the time of the release of software version 1.30.
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2018
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example,…
FDA (openFDA device enforcement)
Reported Apr 25, 2018
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details — Update to cooler-heater cleaning instructions.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2017
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2017
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Product · Product details · Reason for recall — Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2017
Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2017
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Cardiovascular Systems Corporation
Matched: Brand · Reason for recall — Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the…
FDA (openFDA device enforcement)
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