Agency classClass IIOur severity:High FDA (Devices)·Z-1968-2012·Announced 2012-07-18

Terumo Advanced Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump occlusion malfunctions that could prevent pump use.

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 procedures where a malfunction could prevent the use of the pump, fitting the rubric for risk-of-harm products where injury has not yet been reported.

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 occlusion malfunctions, including stiff or difficult-to-adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion, and inability to adjust the occlusion.

These malfunctions could result in the inability to use the pump, which would require replacement with back-up equipment. The affected devices are 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 qualified medical professionals.

The affected units have catalog number 801763 and specific serial numbers ranging from 0011-0335 to 1447-1450. The devices were distributed worldwide, including in the United States and numerous international locations. Medical professionals should check their equipment against the provided serial numbers and contact the manufacturer for instructions on replacement or repair.

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 — Cardiovascular / Perfusion
Hazard: mechanical-malfunction
equipment-failure
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 · mechanical malfunction