Terumo Serial Interface Module Recalled for Data Loss and Smoke Odor
Terumo is recalling 579 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions involving data loss and smoke odor.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device used during cardiopulmonary bypass where malfunctions resulted in data loss and smoke odor, indicating a significant risk of injury or property damage consistent with the 'Severe' rubric criteria.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 579 units of the Serial Interface Module RS-232 (catalog number 802113) used with the Terumo Advanced Perfusion System 1. The module serves as a general-purpose serial interface for transferring perfusion case data, including physiological data and device events, between the system and data management software.
The recall was initiated after the company received reports of malfunctions involving the loss of data transfer capabilities. These failures occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modules. Some reports indicated that the odor of smoke was associated with these failures.
The affected units were distributed worldwide, including across the United States and in various international markets. Users should stop using the affected modules and contact Terumo Cardiovascular Systems Corporation for further instructions on replacement or repair.
The recalled product
- Product
- Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data …
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 579
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 (11)
- catalog number: 802113 and serial numbers: 00007-00036
- 00038-00045
- 00047-00064
- 00066-00077
- 00080-00121
- 00123-00214
- 00216-00283
- 00285-00363
- 00366-00498
- 00500-00548
- and 00550-00597.
Distribution
Part of a larger recall action
This product is one of 4 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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