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Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation Recalls

All product recalls associated with Terumo Cardiovascular Systems Corporation.

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Recall Summary

Total Recalls

451

Past Year

Class I (Serious)

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 341–360 of 451 recalls

Terumo Cardiovascular Systems Corporation: Terumo Backplate Replacement CXFVR 1500 Holder The Fle...

Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a

Class IIModerate

FDAOct 2, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation: Safety monitor included with System 8000 Base The Sarns"...

Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

FDAAug 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

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Terumo Cardiovascular Systems Corporation: Safety monitor included with System 8000 Base The Sarn...

Class IIModerate

FDAAug 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Medtronic CardioVascular: Medtronic Racer Biliary Stent System, Model number XD518Y...

Mislabeling-- The incorrect Instructions for use may have been included with this product.

FDAJul 30, 2009Nationwide• Medtronic CardioVascular

Medtronic CardioVascular: Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm),...

Mislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.

FDAJul 17, 2009AZ, CA, CT +10 more• Medtronic CardioVascular

Terumo Cardiovascular Systems Corporation: Sarns Centrifugal Pump (with X-coating), catalog 164275X,...

The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

FDAJul 6, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation: Sarns Centrifugal Pump (without X-coating), catalog 16427...

The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

FDAJul 6, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Maquet Cardiovascular: Maquet Coronary Perfusion Cannulae with Balloon Tip, with...

Undeclared Allergen

Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.

FDAMay 19, 2009Nationwide• Maquet Cardiovascular

Cardiovascular Systems, Inc.: Diamondback 360 Orbital Atherectomy Device, 1.50 LT Class...

CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s

FDAApr 16, 2009Nationwide• Cardiovascular Systems, Inc.

Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1...

Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com

FDAMar 23, 2009AZ, CA, CO +20 more• Medtronic Cardiovascular Revascularization & Surgical Therap

Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic One Source Pack Magellan, Catalog Number: COS31...

FDAMar 23, 2009AZ, CA, CO +20 more• Medtronic Cardiovascular Revascularization & Surgical Therap

Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS2...

FDAMar 23, 2009AZ, CA, CO +20 more• Medtronic Cardiovascular Revascularization & Surgical Therap

Cardiovascular Systems, Inc.: Diamondback 360, CSI ViperWire Orbital Atherectomy Guide ...

CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.

FDAMar 16, 2009Nationwide• Cardiovascular Systems, Inc.

GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226: GE Healthcare CIC Pro Clinical Information Center Central...

GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.

FDAMar 10, 2009AL, AZ, CA +27 more• GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226

Medtronic Cardiovascular Revascularization & Surgical Therap: Medtronic, Transfer Spike, Blood Processing Accessory, RE...

Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.

FDAFeb 25, 2009IN, MN• Medtronic Cardiovascular Revascularization & Surgical Therap

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 Central Control Monito...

The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.

FDAJan 12, 2009Nationwide• Terumo Cardiovascular Systems Corporation

Medtronic Cardiovascular: Medtronic COMPLETE SE Self Expanding Biliary Stent System...

Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.

FDANov 24, 2008AZ, CA, IN +5 more• Medtronic Cardiovascular

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

FDANov 7, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation: Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6F...

The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.

FDAOct 16, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Medtronic Cardiovascular Revascularization & Surgical Therap: DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/...

Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.

FDASep 29, 2008IL, IN, IA +6 more• Medtronic Cardiovascular Revascularization & Surgical Therap