Ivenix Infusion System Devices Recalled for Alarm Sequencing Defect
The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.
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: This is a Class II medical device recall. The hazard involves a functional alarm failure on a drug infusion system that could delay detection of a critical occlusion event. Although no injuries or illnesses are reported in the source material, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Ivenix, Inc. is recalling 1,335 Ivenix Infusion System (IIS) units due to an alarm sequencing defect. The system may experience a malfunction where a downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. This sequence can mask the true nature of the problem and potentially delay proper diagnosis and response by clinical staff.
The recalled devices were distributed nationwide in New Jersey and Wisconsin. They include specific software version 5.0 with identified system serial numbers. Healthcare facilities using the Ivenix Infusion System should identify affected units by serial number and contact the manufacturer.
Patients and healthcare providers with affected Ivenix Infusion System units should contact Ivenix, Inc. for instructions on device correction or replacement. The manufacturer and FDA are providing guidance on how to handle affected devices.
The recalled product
- Product
- Ivenix Infusion System (IIS)
- Manufacturer
- Ivenix, Inc.
- Affected units
- 1,335
Distribution
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