Terumo Cardiovascular Systems Corp

Complete recall history across all FDA and CPSC categories — 19 total recalls

Terumo Cardiovascular Systems Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Terumo Cardiovascular Systems Corp

Date Product Reason Class
Feb 3, 2022 Cardiovascular Procedure Kit catalog # 76645 & 73806 Potential for Cardiovascular Procedure Kit packaging damage that occurred dur... Class II
Dec 18, 2017 Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukoc... Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoG... Class II
May 12, 2017 Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended f... Kit was labeled with the incorrect Expiration Date of April 30, 2019. Class II
Jul 25, 2016 Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled con... Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface c... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Te... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25R... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
Aug 24, 2015 Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo ... Custom Cardiovascular Procedure Kits contain recalled component Medivators HP... Class II
May 6, 2015 Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use... The Overpressure Safety Valve is not cleared with an indication for use on th... Class II
Mar 28, 2014 Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE... Incorrect customer notification label applied to the Tyvek lid of this speci... Class II
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Us... Defect in the luer connector can compromise the seal on the female side of th... Class II
Mar 1, 2011 Terumo Cardioplegia Delivery Set- Item Number: 16130 Produc... Defect in the luer connector can compromise the seal on the female side of th... Class II
Mar 1, 2011 Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kit... Defect in the luer connector can compromise the seal on the female side of th... Class II
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypa... Defect in the luer connector can compromise the seal on the female side of th... Class II
Mar 1, 2011 Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 ... Defect in the luer connector can compromise the seal on the female side of th... Class II
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog N... Defect in the luer connector can compromise the seal on the female side of th... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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