Autosoft30™ 1002825Recalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Autosoft30 infusion set from Unomedical is a single-use set for delivering fluid under the skin. Its 2,751 reports mostly describe tubing twisted or bent, adhesive not holding, and leaks. The reports include no deaths and 451 injuries, and high blood sugar and diabetic ketoacidosis are among the patient problems listed. Reports in the last 12 months (1,050) are well above the previous 12 months (627). No recalls name this device.
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
- 3,147
- Deaths reported
- 0
- Injuries reported
- 579
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,147 adverse event reports that list this exact device (DI 05705244018365), received between Dec 8, 2020 and Sep 30, 2026 — classified as 579 injuries, 2,568 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (996 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent996
- Loss of or Failure to Bond637
- Premature Separation463
- Leak/Splash365
- Detachment of Device or Device Component191
- Infusion or Flow Problem152
- Device Handling Problem144
- Adverse Event Without Identified Device or Use Problem117
Patient problems
- No Clinical Signs, Symptoms or Conditions1,845
- Hyperglycemia1,086
- Elevated Ketones/ Diabetic Ketoacidosis133
- Unspecified Infection34
- Hemorrhage/Blood Loss/Bleeding20
- Skin Infection11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Skin Inflammation/ Irritation7
Recent adverse event reports
The 25 most recent of 3,147 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6) 2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949305 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6)2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949304 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6) 2026, (b)(6)2026, (b)(6) 2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949301 ↗MalfunctionSep 30, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949298 ↗MalfunctionSep 30, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949293 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6)2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949281 ↗MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949091 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947621 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947620 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947487 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947479 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50947477 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947476 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947077 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a kinked infusion set cannula on (b)(6)2026. The issue was noticed within 3 hours of insertion in the abdomen. As a result, the patient required a correction insulin injection via Multiple Daily Injections.
Patient problems: Hyperglycemia
MAUDE report 50945923 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the two-infusion set fell off during use due to infusion set patch did not stick to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943268 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the two-infusion set fell off during use due to infusion set patch did not stick to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943267 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the three-infusion set fell off during use due to infusion set patch did not stick to skin upon insertion on (b)(6)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943236 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the three-infusion set fell off during use due to infusion set patch did not stick to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943154 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the three-infusion set fell off during use due to infusion set patch did not stick to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943143 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937343 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933011 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931874 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930808 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced hyperglycemia issues on (b)(6) 2026 due to occlusion issue with inconclusive troubleshooting and was treated with correction injection via medical daily injections.
Patient problems: Hyperglycemia
MAUDE report 50929999 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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