FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corp: Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
- Recall number
- Z-1828-2015
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Product
- Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
- Status
- Terminated
- Initiated
- 2015-05-06
- Posted
- 2015-06-23
- Terminated
- 2015-07-27
- Reason
- The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
- Root cause
- Component design/selection
- Action
- Consignees were notified of the recall by phone beginning on 5/7/2015 and a Urgent Medical Device Recall letter, dated 5/7/2015. The letter identified the affected device, reason for recall, potential hazard, and correction. Customers were asked to review the notice and ensure that all users are aware of the issue. In addition, they are to confirm the quantity of procedure kits for return; and, complete and return the Customer Response Form. Customers can call Terumo CVS Customer Service at 1-800-521-2818 with questions.
- Quantity
- 163 devices
- Distribution
- Distributed to the states of MO and FL.
- Lot, serial or model codes
- Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
- 510(k) numbers
- ["K820297"]
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 1000149028
- Firm city
- Ashland
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28