Terumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 992 Advanced Perfusion System I units worldwide due to reported malfunctions in the Air Bubble Detection System, including oversensitivity and false alarms.
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 life-support procedures (cardiopulmonary bypass). While the specific malfunctions (false alarms/oversensitivity) are reported, the source does not explicitly state that patient injuries or deaths occurred, nor does it explicitly state that no injuries occurred. Per the rubric, risk-of-harm products where injury has not yet been reported (or is not explicitly confirmed/denied in the text) fall under High (3). It is not Critical (5) or Severe (4) because no fatalities or confirmed serious injuries are stated in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 992 units of the Terumo Advanced Perfusion System I (System 1 base 100/120V). 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 with Catalog Number 801763 and serial numbers 0011-1450.
The recall was initiated after the manufacturer received several reports over the last three years of malfunctions in the Air Bubble Detection System. These malfunctions manifested as various failure modes, including oversensitivity and false alarms, with various root causes. The issues occurred in systems that were either excluded from prior corrective actions or in systems where previous fixes did not resolve the problem.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Canada, Mexico, Germany, France, and Japan. Healthcare facilities and qualified perfusionists who use this equipment should stop using the affected units and contact Terumo Cardiovascular Systems Corporation for further instructions on corrective actions or replacements.
The recalled product
- Product
- Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- 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 (1)
- Catalog Number 801763 and serial number 0011-1450
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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.
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