Nimbus II PainPRORecalls & reported problems

Infutronix LLC · Ambulatory infusion pump · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This InfuTronix Nimbus II PainPRO is a patient-controlled pain relief pump. Its 186 reports include no deaths and 2 injuries, many describing software installation problems and sudden power loss. There are 2 open recalls: one covers removing the pump from the market over possible battery failure, blockages and system errors, and the other covers an unreleased software version installed by mistake.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 186
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 00817170020086), received between Feb 8, 2018 and May 21, 2024 — classified as 2 injuries, 184 malfunctions.

The most frequently reported specific device problem is “Problem with Software Installation” (89 reports).

2 FDA recall records name this device's identifier, 2 still open.

3 other recalls cover devices cleared under the same FDA submission (K153193); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Feb 21, 2024Class IOpen, Classified
InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
Z-1286-2024 · Root cause: Device Design · Recall details · FDA record ↗
Oct 19, 2021Class IIOpen, Classified
An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
Z-0832-2022 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Device problems

Problem with Software Installation89
Mechanical Problem33
Complete Loss of Power26
No Flow10
Failure to Infuse7
Wrong Label7
Device Markings/Labelling Problem6
Power Problem6

Patient problems

No Clinical Signs, Symptoms or Conditions179
Inadequate Pain Relief4
Anxiety1
Cardiac Arrest1
Dysphagia/ Odynophagia1
Pain1

Recent adverse event reports

The 25 most recent of 186 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 21, 2024Complete Loss of Power; Complete Loss of Power
ON 03/21/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN UNKNOWN ISSUE. HOWEVER, PUMP WAS RETURNED ON 5/7/2024 AND EVALUATED. THE MDR REPORTABILITY OF THIS COMPLAINT WAS BEING UPGRADED TO "YES", AS THE ABRUPT POWER OFF FOUND IN THE EVENT LOG REVIEW WAS DETERMINED TO BE REPORTABLE ACCORDING TO THE UPDATED MDR DECISION TREE GUIDE. NO PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360008 ↗
MalfunctionMay 21, 2024Complete Loss of Power; Complete Loss of Power
PUMP WAS RETURNED ON (B)(6) 2024 AND EVALUATED. THE MDR REPORTABILITY OF THIS COMPLAINT WAS BEING UPGRADED TO "YES", AS THE ABRUPT POWER OFF REPORTED BY THE END USER WAS NOW DETERMINED TO BE REPORTABLE ACCORDING TO THE UPDATED MDR DECISION TREE GUIDE. PATIENT WAS INVOLVED, BUT NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359455 ↗
MalfunctionApr 26, 2024Mechanical Problem; Mechanical Problem
THE FIRST AND ORIGINAL DATE OF INITIAL CONTACT OF THIS COMPLAINT WAS 05/16/2022 AND IT WAS NOT A REPORTABLE EVENT. NO PATIENT WAS HARMED. THE DEVICE WAS RETURNED ON 02/22/2024 FOR FURTHER EVALUATION. ON 04/18/2024, INFUTRONIX INVESTIGATED ON THE RETURNED DEVICE AND DISCOVERED IT HAD AN ISSUE OF ALARM SYSTEM ERROR WHICH WAS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19194043 ↗
MalfunctionApr 15, 2024Complete Loss of Power; Complete Loss of Power
ON 02/20/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD AN " PUMP - ACTS LIKE IT IS RUNNING BUT IS NOT INFUSING ". PATIENT WAS INVOLVED, BUT NOT HARMED. DEVICE WAS RETURNED ON 02/23/2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113073 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 (B)(4) OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101905 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 (B)(6) OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION (B)(6) INSTEAD OF (B)(6). MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101545 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021, (B)(4) OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). (B)(6) HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101500 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 (B)(6) OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101482 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 VANN GRIFFIN OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY RICHARD SAPIENZA. CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101408 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 (B)(6)OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION (B)(6) V4 INSTEAD OF (B)(6) V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101398 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 VANN GRIFFIN OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY RICHARD SAPIENZA. CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101394 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 VANN GRIFFIN OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101392 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 VANN GRIFFIN OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY RICHARD SAPIENZA. CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101391 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/15/2021 VANN GRIFFIN OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY RICHARD SAPIENZA. CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101390 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 (B)(6) OF INFUTRONIX SOLUTIONS WAS NOTIFIED BY (B)(6). CARDINAL HEALTH REPORTED THAT THE PUMP HAD THE INCORRECT LIBRARY CONFIGURATION DUKE V4 INSTEAD OF DUKE V3. MEDICATION N/A. NO PATIENT INVOLVED. NO PATIENT WAS HARMED. DEVICE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19101331 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/19/2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095306 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/19/2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095305 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/19/2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095260 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON 10/19/2021, A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095245 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION (B)(6) PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED (B)(6)PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095223 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095203 ↗
MalfunctionApr 12, 2024Problem with Software Installation; Problem with Software Installation
ON (B)(6) 2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION (B)(6) PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED (B)(6) PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095181 ↗
MalfunctionApr 11, 2024Problem with Software Installation; Problem with Software Installation
ON 05/19/2022, INFUTRONIX RECEIVED A REPORT FROM A HEALTHCARE FACILITY THAT THE PUMP WAS CONFIGURED INCORRECTLY. THE REPORTER INDICATED THAT THE PUMP HAD AN INCORRECT LIBRARY CONFIGURATION. NO PATIENT WAS INVOLVED IN THE REPORTED EVENT. DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19093777 ↗
MalfunctionApr 11, 2024Problem with Software Installation; Problem with Software Installation
ON 05/19/2022, INFUTRONIX RECEIVED A REPORT FROM A HEALTHCARE FACILITY THAT THE PUMP WAS CONFIGURED INCORRECTLY. THE REPORTER INDICATED THAT THE PUMP HAD AN INCORRECT LIBRARY CONFIGURATION. NO PATIENT WAS INVOLVED IN THE REPORTED EVENT. DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19093760 ↗
MalfunctionApr 11, 2024Problem with Software Installation; Problem with Software Installation
ON 05/19/2022, INFUTRONIX RECEIVED A REPORT FROM A HEALTHCARE FACILITY THAT THE PUMP WAS CONFIGURED INCORRECTLY. THE REPORTER INDICATED THAT THE PUMP HAD AN INCORRECT LIBRARY CONFIGURATION. NO PATIENT WAS INVOLVED IN THE REPORTED EVENT. DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19093708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153193. One submission often covers many models, so check the product and lot details in each record.

Z-1811-2024 · Apr 18, 2024 · Open, Classified
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Z-1285-2024 · Feb 21, 2024 · Open, Classified
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Z-2055-2019 · May 28, 2019 · Terminated
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

Device details

UDI-DI	`00817170020086`
Brand	Nimbus II PainPRO
Model	Nimbus II PainPRO
Company	Infutronix LLC
Product code	MEA · Pump, Infusion, Pca
Class	Class 2
FDA submission	K153193
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 7, 2024

Device type (GMDN): Patient-controlled analgesia infusion pump

A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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