Accu-Chek Link Assist 04530039001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Link Assist · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04015630048601), received between Dec 27, 2019 and Dec 18, 2023 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Unintended Ejection” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Ejection8
- Misfire6
- Ejection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient7
- Abrasion1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18350662 ↗MalfunctionJan 24, 2023Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16231458 ↗MalfunctionJul 14, 2022Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013682 ↗MalfunctionJul 7, 2022Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. THE CUSTOMER RECEIVED SCRATCHES ON HER HAND, BUT NO MEDICAL TREATMENT WAS REQUIRED.
Patient problems: Abrasion
MAUDE report 14948519 ↗MalfunctionMar 4, 2022Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13665678 ↗MalfunctionNov 1, 2021Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12730647 ↗MalfunctionMay 17, 2021Misfire; Misfire
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11832925 ↗MalfunctionMar 25, 2021Ejection Problem; Ejection Problem
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. THE CUSTOMER FURTHER ALLEGED THE DEVICE IS NOT BLOCKED BUT IT IS RELEASED WITH DIFFICULTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11567950 ↗MalfunctionNov 30, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. THE CANNULA FIRED INTO THE SIDE OF THE PATIENT'S STOMACH, BUT NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10919811 ↗MalfunctionJul 29, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10337537 ↗MalfunctionJul 21, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10301910 ↗MalfunctionJun 8, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10131135 ↗MalfunctionFeb 13, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9708984 ↗MalfunctionJan 6, 2020Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9553396 ↗MalfunctionDec 27, 2019Unintended Ejection; Unintended Ejection
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9523182 ↗
Other Introducer, Syringe Needle devices
- Autoject 2 AJ1060Owen Mumford Limited · Introducer, Syringe Needle3 reports
- Whisperject 400527460Mylan Pharmaceuticals Inc. · Introducer, Syringe Needle1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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