Autosoft90™ 1002817Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
All models of Autosoft90 (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical Autosoft90 infusion set is named in 9,902 adverse event reports, including 1,678 injuries and no deaths. The reports mostly describe cannulas that bend or kink and sets that come off during use, with some mentioning high blood sugar. One closed recall, from July 2022, concerns instructions that give the wrong insulin fill value for two cannula sizes. Reports in the last 12 months number 4,322, up from 2,282 the year before.
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
- 11,907
- Deaths reported
- 0
- Injuries reported
- 2,269
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11,907 adverse event reports that list this exact device (DI 05705244018129), received between Jan 7, 2021 and Sep 30, 2026 — classified as 2,269 injuries, 9,637 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4,464 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jul 21, 2022Terminated
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Z-1810-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent4,464
- Loss of or Failure to Bond2,987
- Premature Separation2,501
- Leak/Splash903
- Detachment of Device or Device Component787
- Complete Blockage730
- Use of Incorrect Control/Treatment Settings422
- Fluid/Blood Leak404
Patient problems
- No Clinical Signs, Symptoms or Conditions7,784
- Hyperglycemia3,460
- Elevated Ketones/ Diabetic Ketoacidosis513
- Hemorrhage/Blood Loss/Bleeding63
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available32
- Skin Inflammation/ Irritation27
- Hypoglycemia22
- Tissue Breakdown20
Recent adverse event reports
The 25 most recent of 11,907 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951057 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951050 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949583 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that three infusion sets infusion set fell off during use on (b)(6)2026, (b)(6)2026, (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949291 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that three infusion sets infusion set fell off during use on (b)(6)2026, (b)(6)2026, (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949286 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949284 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948600 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent and resulted in Hyperglycemia resolved by infusion set change on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50948226 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent and resulted in Hyperglycemia resolved by infusion set change on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948220 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent and resulted in Hyperglycemia resolved by infusion set change on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947963 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent and resulted in Hyperglycemia resolved by infusion set change on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947962 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where cannula was bent and resulted in Hyperglycemia on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947829 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50947827 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where cannula was bent and resulted in Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947616 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was kinked resulted in occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947500 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was kinked resulted in occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947497 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent resulted in occlusion on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947481 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent resulted in occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947480 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set used for three hours resulted in kinked cannula led to the occlusion at the site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947073 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
It was reported that the patient experienced infusion set having a difficulty removing infusion set tubing from site at connector event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946887 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the kinked cannula resulted in Hyperglycemia treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50945940 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced an infusion set cannula kink on (b)(6)-2026. This issue caused multiple occlusion issues, which led to elevated blood glucose levels. The high blood sugar was treated and managed with a correction injection via multiple daily injections (MDI) and boluses.
Patient problems: Hyperglycemia
MAUDE report 50945939 ↗InjurySep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50945934 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced an infusion set cannula kink on (b)(6)2026. This issue caused multiple occlusion issues, which led to elevated blood glucose levels. The high blood sugar was treated and managed with a correction injection via multiple daily injections (MDI) and boluses.
Patient problems: Hyperglycemia
MAUDE report 50945931 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6)2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945320 ↗
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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 16, 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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