Terumo Cardiovascular Systems Corporation Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
No lot/serial number, Catalog number: PN 816280
Products Sold
No lot/serial number; Catalog number: PN 816280
Terumo Cardiovascular Systems Corporation is recalling Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Back due to Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026