Accu-Chek TenderLink™ 04541642001Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244008656), received between Feb 12, 2020 and Nov 12, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hyperglycemia1
- Reaction, Injection Site1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN NETHERLANDS. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA LEAKING EVENT ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662668 ↗MalfunctionDec 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, THAT THE CONNECTION OF THE INFUSION SET WAS LEAKING. THE CUSTOMER INSISTED THAT THE LEAK WAS FROM THE CANNULA, NOT THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13109204 ↗InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CALLER REPORTED ALLERGIC REACTIONS AND INFECTIONS WHILE WEARING THE TENDERLINK CANNULA'S. THE CALLER REPORTED AN ALLERGY SINCE (B)(6) 2019, BUT RECENTLY GOT AN INFECTION. THE PATIENT REPORTED HAVING 3 MEDICAL PROCEDURES TO DRAIN THE PUS FROM THE SITE. THE CALLER REPORTED SYMPTOMS OF ITCHING AND REDNESS AT THE SITE. CALLER ALLEGED THAT DUE TO INFECTIONS BLOOD GLUCOSE LEVELS HAVE INCREASED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION. THE TYPE OF ANTIBIOTIC PRESCRIBED WAS UNKNOWN. IT IS UNKNOWN HOW LONG THE PATIENT WAS HOSPITALIZED OR IF THESE WERE OUTPATIENT PROCEDURES.
Patient problems: Hyperglycemia; Reaction, Injection Site; Unspecified Infection
MAUDE report 9699586 ↗
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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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