The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2178-2012·Announced 2012-08-15

Terumo Advanced Perfusion System 1 recalled for module malfunctions

Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.

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 is classified as FDA Class II. The hazard involves a medical device used in life-support procedures (cardiopulmonary bypass) where module malfunctions could pose a risk of harm, but the source text does not report specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 649 units of the Terumo Advanced Perfusion System 1 (220/240V) due to malfunctions in the Occluder and Air Bubble Detection (ABD) Modules. The investigation determined that a faulty component on the modules' application board caused the failures. The affected units are identified by catalog number 801764 and specific serial number ranges.

The recall covers units distributed worldwide, including the United States and numerous international markets such as Canada, Australia, and various countries in Europe, Asia, and the Middle East. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, and must be used by a qualified perfusionist.

This recall follows a Safety Advisory (AA-2010-007-C) issued on December 2, 2010, regarding these specific module malfunctions. Users of the affected equipment should contact Terumo Cardiovascular Systems Corporation for further instructions on the recall and corrective actions.

The recalled product

Product
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the…
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
649

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: 801764 and serial numbers: 0006-0066
  • 0100-0311
  • 0313-0322
  • 1001-1027
  • 1100-1434
  • 1436
  • 1440
  • and 1441.

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 →

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