Accu-Chek Rapid-D Link 04541065001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Rapid-D Link Tra. Set 50 10pcs · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630046072), received between Jul 22, 2020 and Dec 30, 2024 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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
- Fluid/Blood Leak7
- Material Integrity Problem3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Hyperglycemia4
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem
IT HAS BEEN REPORTED THAT THE TRANSFER SET CANNOT BE TIGHTENED ON THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21034327 ↗MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem
IT HAS BEEN REPORTED THAT THE TRANSFER SET CANNOT BE TIGHTENED ON THE CARTRIDGE. THE ISSUE OCCURRED FOUR TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21034319 ↗MalfunctionDec 30, 2024Material Integrity Problem; Material Integrity Problem
IT HAS BEEN REPORTED THAT THE TRANSFER SET CANNOT BE TIGHTENED ON THE CARTRIDGE. THE ISSUE OCCURRED TWICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21034307 ↗InjurySep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET, WHICH RESULTED IN ELEVATED BLOOD GLUCOSE RESULTS. BASED ON THE HIGH RESULTS THE CUSTOMER WENT TO THE HOSPITAL TO CONSULT WITH THE DIABETES NURSE AND TO OBTAIN BACK UP PEN THERAPY. THE BLOOD GLUCOSE RESULTS OBTAINED AT THE HOSPITAL WERE NOT PROVIDED, HOWEVER THE NURSE ADMINISTERED AN INSULIN INJECTION TO LOWER THE CUSTOMER'S BLOOD GLUCOSE LEVELS. THE CUSTOMER LEFT THE HOSPITAL AFTER ONE HOUR.
Patient problems: Hyperglycemia
MAUDE report 20199663 ↗MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE TRANSFER SET RESULTING IN HIGH BLOOD GLUCOSE LEVELS BETWEEN 300 MG/DL - 400 MG/DL. THE ISSUE OCCURRED WITH 3 PIECES FROM THE SAME BATCH, EACH ONE IN A ROW BETWEEN (B)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 20144010 ↗MalfunctionJul 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING BETWEEN THE TUBING, CARTRIDGE AND ADAPTER RESULTING IN ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 19770174 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TRANSFER SET WAS LEAKING AT THE AT THE CONNECTOR CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19665245 ↗MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE TRANSFER SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18614808 ↗MalfunctionJan 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE TRANSFER SET. THE ISSUE OCCURRED WITH FIVE INFUSIONS SETS OF THE SAME BATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18560096 ↗MalfunctionJul 22, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LUER LOCK OF THE INFUSION TUBING HAD DISCONNECTED FROM THE ADAPTER, WHICH RESULTED IN AN INSULIN LEAK AND ELEVATED BLOOD GLUCOSE LEVELS.
Patient problems: Hyperglycemia
MAUDE report 10308377 ↗
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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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