Custom Cardiovascular Procedure Kits recallZ-1828-2015 · Terumo Cardiovascular Systems Corp · initiated May 6, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1828-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 6, 2015
- Posted by the FDA
- Jun 23, 2015
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 163 devices
- Product code
- DTL
- FDA submissions
- K820297
- Distribution
- Distributed to the states of MO and FL.
Product description
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.
Code information (models, lots, serial numbers)
Part Number: 66086-01: Lot Numbers: RG09, RM20 and Part Number: 70700-03: Lot Numbers: QL09, RH07, RL15, QG17, RD03
Other devices under the same FDA submission
2 devices cleared under K820297 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Overpressure Safety Valve LH130Terumo Cardiovascular Systems Corporation · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass6 reports
- Overpressure Safety Valve - Japan LH130JTerumo Cardiovascular Systems Corporation · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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