Agency classClass IIOur severity:High FDA (Devices)·Z-1970-2012·Announced 2012-07-18

Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device used in critical surgeries where a malfunction could lead to serious harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System 1 Base 100/120V. The recall is due to reports of various roller pump malfunctions, including unplanned pump stops, pauses, and changes in pump speed. These issues could result in the inability to use the pump, requiring replacement with back-up equipment during procedures.

The affected devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The recall covers units distributed worldwide, including the United States and numerous international locations. Affected units have catalog number 801763 and specific serial numbers ranging from 0011-0335 to 1447-1450.

Qualified medical professionals using this equipment should check their inventory for the affected serial numbers. If a malfunction occurs during a procedure, the source text notes that replacement with back-up equipment would be required.

The recalled product

Product: System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiopulmonary Bypass
Hazard: device-malfunction
loss-of-function
Affected units: 992

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 (8)

catalog number: 801763 and serial numbers: 0011-0335
0337-0610
1001-1034
1037-1049
1100
1103-1106
1109-1445
and 1447-1450.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · device malfunction