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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

OptumHealth Care Solutions LLC: Nimbus II Plus Infusion Pumps Recalled for Potential Failure and Leakage

Agency Publication Date: May 21, 2024
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Summary

OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus Ambulatory Infusion Pump (Model AAA-00170) due to multiple critical failure modes. These devices, manufactured by InfuTronix, are being removed from the market because they can experience battery failures, system errors, drug leaks, and incorrect flow rates. If these pumps fail during use, patients may receive the wrong dose of medication or have their treatment interrupted entirely.

Risk

The infusion pump may fail to deliver medication accurately or stop working suddenly due to hardware defects or software errors, which could lead to a life-threatening delay in therapy or an overdose. Specific risks include drug product leakage, damaged pump housing, and flow rates that are either too high or too low.

What You Should Do

  1. Check your infusion pump for the model number 'AAA-00170' and the brand name 'Optum Nimbus II Plus'.
  2. Verify the serial number and lot number on the back or side of your device against the list of 208 affected units, which includes specific IDs such as 302604 / NIMBP702231, 318050 / NIMBP715656, and 340086 / NIMBS718475 among others.
  3. If you identify an affected pump, contact your healthcare provider immediately to discuss alternative infusion options and to ensure your treatment is not interrupted.
  4. Contact OptumHealth Care Solutions LLC or the manufacturer, InfuTronix, to arrange for the return of the device and to receive further instructions regarding a replacement or remedy.
  5. For additional information or questions about this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Market removal/Device return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Optum Nimbus II Plus Ambulatory Infusion Pump
Model / REF:
AAA-00170
UPC Codes:
00862492000308
Lot Numbers (208):
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
343066 / NIMBS716125
343309 / NIMBS719492
343683 / NIMBS716506
344023 / NIMBS716532
344044 / NIMBS718477
344173 / NIMBS718500
344273 / NIMBS715037
344407 / NIMBS709122
344440 / NIMBS709111
344450 / NIMBS708973
344455 / NIMBS709568
344572 / NIMBS709989
344588 / NIMBS708676
344692 / NIMBS709563
344783 / NIMBS709112
344853 / NIMBS709482
344862 / NIMBS709556
344976 / NIMBS709267
345057 / NIMBS716989
345060 / NIMBS716509
345190 / NIMBS708707
345195 / NIMBS719668
345396 / NIMBS718671
345397 / NIMBS708966
345443 / NIMBS716367
345446 / NIMBS719686
345728 / NIMBS718488
345732 / NIMBS716946
345774 / NIMBS716166
345872 / NIMBS709020
345879 / NIMBS716159
346002 / NIMBS716398

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94491
Status: Active
Manufacturer: OptumHealth Care Solutions LLC
Sold By: OptumHealth Care Solutions LLC
Manufactured In: United States
Units Affected: 208 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.