Terumo Cardiovascular Custom Cardiovascular Procedure Kits… recallZ-0603-2014 · Terumo Cardiovascular Systems Corporation · initiated Jun 4, 2013
Class II Terminated All recalls posted in December 2013
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 Corporation 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
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
FDA root cause category: Component design/selection
What the company is doing
Terumo Cardiovascular issued Customer notification letters on June 4, 2013. Accounts advised to: Review this notice and decide to continue to use or not use the Cardiovascular Procedure Kits as configured until a replacement kit with a one-way valve indicated for use on the arterial side of the perfusion circuit is available. If you have questions, contact Terumo CVS Customer Service: 800-521-2818.
Recall details
- Recall number
- Z-0603-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 4, 2013
- Posted by the FDA
- Dec 27, 2013
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 24,227.
- Product code
- MNJ
- FDA submissions
- K820297
- Distribution
- Nationwide Canada
Product description
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Code information (models, lots, serial numbers)
N/A
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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