Accu-Chek TenderLink™ 04541600001Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244008502), received between Feb 15, 2019 and Jul 27, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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
- Leak/Splash3
- Detachment of Device or Device Component1
- Failure to Deliver1
- Fluid/Blood Leak1
- Loss of or Failure to Bond1
- Material Perforation1
- Material Twisted/Bent1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hyperglycemia2
- Cramp(s)1
- Loss of consciousness1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031254 ↗MalfunctionMar 12, 2025Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET CANNULA WAS LEAKING AT THE CONNECTION WHICH OCCURRED ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE PATIENT WAS FEELING WELL. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582477 ↗MalfunctionNov 8, 2024Leak/Splash; Leak/Splash
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639212 ↗MalfunctionOct 6, 2023Material Perforation; Material Perforation
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. THE PATIENT'S FATHER REPORTED THAT HIS CHILD'S INFUSION SET'S SOFT CANNULA MELTED (IT WAS SOFTER) AND IT WAS BENT WHEN HE TOOK IT OUT. HE THINKS THAT THIS ISSUE OCCURRED DUE TO THE WEATHER (35 DEGREES). NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17884204 ↗MalfunctionJan 15, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE IS LEAKAGE AROUND THE PUMP ADAPTER AND INFUSION SET CONNECTION.
Patient problems: Hyperglycemia
MAUDE report 9592364 ↗InjuryApr 25, 2019Leak/Splash; Failure to Deliver; Material Twisted/Bent; Noise, Audible
(B)(4). (B)(6) - INCIDENT DATA FROM A ROCHE DIABETES CARE COMMUNICATION TO UNOMEDICAL. (B)(4): ON (B)(6) 2019 CUSTOMER INSERTED AN AC TENDERLINK 13MM/60CM; AFTER 5-6 HOURS BLOOD GLUCOSE VALUE INCREASED TO UP TO 500 MG/DL. ON (B)(6) 2019 AT 01:00 A.M. BLOOD GLUCOSE VALUE WAS 360 MG/DL. CORRECTION VIA SYRINGE. IN THE NIGHT THE ROOMMATE FOUND THE CUSTOMER UNRESPONSIVE/UNCONSCIOUS WITH CRAMPS IN HIS BED. THE ROOMMATE CALLED THE EMERGENCY DOCTOR. CUSTOMER GOT AN INFUSION (UNKNOWN) AND WAS DRIVEN TO THE (B)(6). RELEASED FROM THE HOSPITAL ON (B)(6) 2019 AFTER RECEIVING THE REPLACEMENT PUMP. NOW EVERYTHING O.K. THE CUSTOMER NOTICED THAT THERE WAS A LEAK AT THE SOFT CANNULA AND THE NEEDLE WAS BENT. FURTHERMORE CUSTOMER ASSUMES THE PUMP DOESN'T DELIVER INSULIN CORRECTLY AND PUMP MAKES ABNORMAL NOISES.
Patient problems: Cramp(s); Hyperglycemia; Loss of consciousness
MAUDE report 8548637 ↗MalfunctionFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE TUBE AT THE LEVEL OF CONNECTION PART WITH NEEDLE GOT LOOSE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8342369 ↗
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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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