Rate Flow® L2590260-US5300Recalls & reported problems
Leventon Sau · Rate Flow® Regulator Extension Set with Rate Flow Regulator, ULTRASITE® Injection Site, and Spin-Lock® Connector · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08436020767234), received between Oct 16, 2018 and Oct 16, 2018 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (10 reports).
1 other recall cover devices cleared under the same FDA submission (K851058); 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.
Most reported problems
Device problems
- Excess Flow or Over-Infusion10
Patient problems
- No Consequences Or Impact To Patient8
- No Patient Involvement2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 1. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969283 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 2. AN "IN HOUSE" TEST OF THE PRODUCT USING A 1 LITER BAG OF FLUID AND THE SAME GRAVITY TUBING THAT IS BEING USED IN THE COMMUNITY WAS PERFORMED. CUSTOMER DID FOLLOW THE DIRECTIONS FOR SET UP OF THE SYSTEM INCLUDING HEIGHT REQUIREMENTS; ETC. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR; WHICH SHOULD HAVE INFUSED OVER 4 HOURS; BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7969280 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: EVENT 1. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969271 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 2- AN "IN HOUSE" TEST OF THE PRODUCT USING A 1 LITER BAG OF FLUID AND THE SAME GRAVITY TUBING THAT IS BEING USED IN THE COMMUNITY WAS PERFORMED. CUSTOMER DID FOLLOW THE DIRECTIONS FOR SET UP OF THE SYSTEM INCLUDING HEIGHT REQUIREMENTS; ETC. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR; WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7969268 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: EVENT 5. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969267 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: EVENT 3. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR; WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969265 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: EVENT 2. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969264 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR; WHICH SHOULD HAVE INFUSED OVER 4 HOURS; BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969263 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: EVENT 4- THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969261 ↗MalfunctionOct 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY USER FACILITY: EVENT 1. THE FLOW REGULATOR WAS SET TO INFUSE AT 250 ML/HR, WHICH SHOULD HAVE INFUSED OVER 4 HOURS, BUT THE IV FLUID RAN THROUGH IN JUST UNDER 2 HOURS. NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969259 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K851058. One submission often covers many models, so check the product and lot details in each record.
- Z-2601-2011 · Mar 11, 2011 · Terminated"***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON,
Other Set, Administration, Intravascular devices
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 16, 2026
- 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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