Food, drugs, devices › Terumo Cardiovascular Systems Corp
Device recall: Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the ca
FDA enforcement event 71196 is a device recall by Terumo Cardiovascular Systems Corp of Ashland, MA, initiated 6 May 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 27 Jul 2015. Initiation: voluntary: firm initiated. Terumo Cardiovascular Systems Corp has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Terumo Cardiovascular Systems Corp, Ashland, MA.
Reason for recall
"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."
Distribution
"Distributed to the states of MO and FL."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1828-2015 | 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. | 163 devices | Class II | Terminated | 1 Jul 2015 |
Context
Other enforcement events for Terumo Cardiovascular Systems Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Feb 2022 | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Device | Class II | 1 |
| 18 Dec 2017 | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The C | Device | Class II | 1 |
| 12 May 2017 | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of th | Device | Class II | 1 |
| 25 Jul 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This prod | Device | Class II | 1 |
| 24 Aug 2015 | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufacture | Device | Class II | 7 |
| 28 Mar 2014 | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 | Device | Class II | 1 |
| 1 Mar 2011 | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: | Device | Class II | 6 |
All 8 events for Terumo Cardiovascular Systems Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to the states of MO and FL."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Jul 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.