Terumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves
Terumo is recalling 163 custom cardiovascular procedure kits and over-pressure safety valves because the valves are not cleared for use on the arterial side of the bypass circuit.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly describes the risk as a 'remote possibility' of 'minimal' injury, fitting the criteria for a moderate severity voluntary precautionary recall without reported serious injuries.
Plain-English summary
Terumo Cardiovascular Systems Corp is recalling 163 units of Custom Cardiovascular Procedure Kits and Over-Pressure Safety Valves. These devices are intended for use only in the extracorporeal circuit for cardiopulmonary bypass procedures specifically designed by the user.
The recall is being conducted because the Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. The device is intended for use only on the venous side. The source text notes a remote possibility of minimal blood loss, fluid weeping, or dripping on the user if the device is used incorrectly.
The affected devices were distributed to the states of Missouri and Florida. The specific part numbers and lot numbers involved are 66086-01 (Lot Numbers: RG09, RM20) and 70700-03 (Lot Numbers: QL09, RH07, RL15, QG17, RD03). Users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 163
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Part Number: 66086-01: Lot Numbers: RG09
- RM20 and Part Number: 70700-03: Lot Numbers: QL09
- RH07
- RL15
- QG17
- RD03
Distribution
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