Accu-Chek TenderLinkRecalls & reported problems across all models

We found 8 models of Accu-Chek TenderLink by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2019 and Jul 27, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Accu-Chek TenderLink problems

Accu-Chek TenderLink models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Accu-Chek TenderLink™ 04541600001

  Set, Administration, Intravascular
  7 reports
• Accu-Chek TenderLink™ 05015260001

  Set, Administration, Intravascular
  4 reports
• Accu-Chek TenderLink™ 04541596001

  Set, Administration, Intravascular
  3 reports
• Accu-Chek TenderLink™ 04541642001

  Set, Administration, Intravascular
  3 reports
• Accu-Chek TenderLink™ 05015251001

  Set, Administration, Intravascular
  2 reports
• Accu-Chek TenderLink™ 04541634001

  Set, Administration, Intravascular
  1 report
• Accu-Chek TenderLink™ 04541618001

  Set, Administration, Intravascular
  1 report
• Accu-Chek TenderLink™ 04541626001

  Set, Administration, Intravascular
  1 report

Recent Accu-Chek TenderLink adverse event reports

The 15 most recent reports across all models, 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 22, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRIA IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT. LEAKAGE WAS BETWEEN CONNECTION TO THE ADAPTER AND CARTRIDGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755948 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 26, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET LEAKS IN THE TUBING SITE. NO FURTHER INFORMATION AVAILABLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308701 ↗
• MalfunctionSep 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE INFUSION SETS FROM THE SAME PACKAGE WERE LEAKING AT THE HEADSET AFTER THE DELIVERY OF A BOLUS ON THREE DIFFERENT DAYS. THIS LED TO A WET SELF-ADHESIVE PLASTER AND HIGH BLOOD GLUCOSE LEVELS UP TO 400 MG/DL.

  Patient problems: Hyperglycemia

  MAUDE report 20169583 ↗
• MalfunctionJul 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19700471 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11095998 ↗
• 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 ↗
• MalfunctionJul 7, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SELF-ADHESIVE OF THE INFUSION SET WAS NOT STICKING WELL ENOUGH. HE STATED THIS OCCURRED WITH ABOUT 20 HEADSETS IN ONE WEEK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10241012 ↗

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