Accu-Chek TenderLink™ 04541596001Recalls & 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 Accu-Chek TenderLink (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244008359), received between Aug 19, 2020 and Sep 14, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INFUSION TUBING HAD DETACHED FROM THE CONNECTOR OF THE INFUSION SET. INFUSION TUBING HAD DETACHED FROM THE CONNECTOR OF THE INFUSION SET. THE PATIENT MENTIONED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417345 ↗MalfunctionJan 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13247611 ↗MalfunctionAug 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SELF-ADHESIVE OF THE INFUSION SET WAS WET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10425448 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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
- 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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