Infusion pump recalled for mechanical valve interference interrupting therapy delivery
Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I medical device recall mandates minimum severity score of 4 per the rubric. No actual deaths or injuries are reported in the source, preventing a higher classification. The mechanical defect threatens therapy continuity with risk of serious patient harm.
Plain-English summary
The FDA has recalled the Ivenix Infusion System (IIS) Large Volume Pump LVP-0004 manufactured by Fresenius Kabi USA, LLC. The device is used to deliver intravenous fluids and medications to patients.
The pump may experience mechanical interference on the fluid valve pins, which triggers a Pump Problem alarm and may delay or interrupt drug and fluid delivery during patient treatment.
The recall affects 938 units distributed across California, Colorado, New Jersey, Utah, and Wisconsin. Healthcare facilities and patients currently using this device may be affected.
Patients and healthcare providers who have this device should contact Fresenius Kabi USA, LLC immediately. Depending on the therapy and duration of any therapy delay or interruption, patients may face serious harm. The FDA urges immediate action to discontinue use and determine appropriate alternative therapy options.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 938
Distribution
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