The Recall Desk
SevereFDA (Devices)·Z-0285-2013·Announced 2012-11-21

Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions

Terumo CVS is recalling 81 Sarns Modular Perfusion System 8000 units due to arterial and cardioplegia monitor malfunctions, including power issues and inaccurate pressure alarms.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies this as an FDA Class II recall involving a medical device used for cardiopulmonary bypass. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are classified as Severe (4). While specific injury counts are not detailed in the provided snippet, the nature of the device and the agency classification align with the Severe criteria for medical devices with reported malfunctions affecting safety monitoring.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 81 units of the Sarns Modular Perfusion System 8000, base 5 pump, with 100V safety monitor included. The affected units have catalog number 16410 and serial numbers 1001-1034, 1036-1061, and 1602-1622. The recall covers units distributed worldwide, including the United States and various international locations.

The recall was initiated after Terumo CVS received multiple reports since 2007 of various malfunctions in the arterial and cardioplegia monitors. These malfunctions include monitor power failures, the inability to measure pressure, and inaccurate or false pressure alarms. The Sarns Modular Perfusion System 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

Healthcare facilities and users should stop using the affected units and contact Terumo CVS for further instructions on the recall process. The agency has classified this as a Class II recall.

The recalled product

Product
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 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 u
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular / Perfusion
Hazard
Affected units
81

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 (3)

  • catalog number: 16410 serial numbers:1001-1034
  • 1036-1061
  • and 1602-1622.

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →

Same hazard · monitor malfunction

See all →