Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
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 classification applies to medical devices with an imminent health hazard. While no illnesses or deaths are reported, the multiple potential failure modes—battery failure, system errors, drug leakage, and abnormal flow rates—in an infusion pump could compromise medication delivery and patient safety.
Plain-English summary
OptumHealth Care Solutions LLC is recalling the Optum Nimbus II Plus, Model AAA-00170, an ambulatory infusion pump used to deliver medication. This recall affects 208 units distributed nationwide in the United States.
The pump is being recalled due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, abnormal flow rates, and damaged pump housing. These failures could affect the safe and accurate delivery of medications to patients.
Patients and healthcare providers should verify whether their device matches one of the recalled lot numbers and serial numbers listed in the FDA recall notice. Affected individuals should contact the manufacturer, OptumHealth Care Solutions LLC, for guidance on next steps regarding their specific device.
The recalled product
- Product
- Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
- Manufacturer
- OptumHealth Care Solutions LLC
- Affected units
- 208
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 (20)
- UDI/DI 00862492000308
- Each unit has a Lot Number and a Serial Number
- listed as follows: Lot Number/Serial Number: 302604 / NIMBP702231
- 318050 / NIMBP715656
- 340086 / NIMBS718475
- 340163 / NIMBS716926
- 340648 / NIMBS716122
- 340746 / NIMBS715845
- 340820 / NIMBS712929
- 340903 / NIMBP719704
- 341046 / NIMBS713994
- 341372 / NIMBS718513
- 341535 / NIMBS718700
- 341757 / NIMBS716661
- 341770 / NIMBS716996
- 342136 / NIMBS715836
- 342233 / NIMBS718503
- 342350 / NIMBS714995
- 342447 / NIMBS713444
- 342938 / NIMBS716864
Distribution
Distributed nationwide across the United States.
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