Pump, Infusion, Enteral
FDA adverse event reports and recall history for pump, infusion, enteral (product code LZH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 14,875
- Deaths
- 85
- Injuries
- 393
- Malfunctions
- 14,209
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-01-31TerminatedNonconforming Material/Component
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
- 2012-11-15TerminatedComponent design/selection
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
- 2011-10-25TerminatedProcess control
CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. Intended to deliver formula to patients requiring tube feedings.
Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.
- 2009-09-21TerminatedSoftware design (manufacturing process)
EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. A rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.
Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
- 2009-09-21TerminatedSoftware design (manufacturing process)
Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123.
Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
- 2009-09-21TerminatedDevice Design
Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care.
The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps, have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.
- 2008-09-20TerminatedLabeling mix-ups
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients.
Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set."
- 2007-08-08TerminatedEquipment maintenance
Embrace Enteral Pump
Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
- 2007-08-07TerminatedEquipment maintenance
The Companion ClearStar Pump System, for enteral feeding.
The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.
- 2005-03-08TerminatedOther
Flexiflo Quantum Enteral Pump
Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
Monitor pump, infusion, enteral automatically
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