The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names:
- Nimbus: Administration Set, Flex, PainPro, also known as the Halo Ambulatory Infusion System
- Nimbus II: PainPRO, Flex, Plus, EpiD, and EMS
- Product Codes: See Recall Database Entries
- Distribution Dates: February 27, 2015 to February 29, 2024
- Devices Recalled in the U.S.: 52,328
- Date Initiated by Firm: February 21, 2024
Device Use
The Nimbus Administration Set, Flex, and PainPro, also known as the Halo Ambulatory Infusion System, as well as the Nimbus II PainPRO, Flex, Plus, EpiD, and EMS infusion pumps (Nimbus infusion pump systems) are intended to deliver medications and/or fluids to a patient under the direction or supervision of a doctor or other certified health care professional. These devices are used for infusions under or through the skin (subcutaneous or percutaneous), in the spaces between nerves (perineural or epidural), or into blood vessels (intravenous). The pumps are sometimes also used for patients to deliver their own pain medications (patient-controlled analgesia, or PCA).
Nimbus infusion pump systems are used in hospitals, other healthcare facilities, and in nonclinical environments such as patient homes.
Reason for Recall
InfuTronix, LLC is recalling Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. The devices will not be available or supported after June 20, 2024.
Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage), interruptions or delays in therapy from unnoticed occlusion may lead to underdosing of vital medications and fluids resulting in uncontrolled hypertension (high blood pressure), dehydration (water loss), and electrolyte imbalance; seizures, shock and organ failure may occur.) Use of these products may lead to serious injury or death.
InfuTronix reports 3,698 complaints, six serious injuries, and one death related to this issue.
Who May be Affected
- Health care providers using Nimbus infusion pump systems.
- Patients who currently receive infusions using Nimbus infusion pump systems or whose care might typically be delivered using these infusion pumps.
What to Do
On February 21, 2024, InfuTronix sent customers an Urgent Medical Device Removal letter informing them that the identified Nimbus infusion pump systems are being removed from the market. The letter noted that the products will no longer be supported by InfuTronix after June 20, 2024, and included the following recommended actions:
- Customers who have Nimbus infusion pump systems in their possession should contact InfuTronix customer service: [email protected]. They will be instructed on the Return Material Authorization (RMA) process for returning Nimbus Infusion Pumps and associated infusion sets.
- Health care providers are encouraged to seek alternative methods of drug product infusion at the earliest possible opportunity, based on their medical expertise of what is appropriate for patient needs.
Contact Information
Customers with questions about this recall should contact InfuTronix Customer Service at (508) 650-2008.
