Silhouette® Paradigm® MMT-377600Recalls & 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 Silhouette Paradigm (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244009318), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Most reported problems
Device problems
- Crack1
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2021Crack; Crack
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT HER WIFE FELL AND HIT HERSELF AND THAT IS WHEN THE TUBING CONNECTOR BROKE, BUT SHE DID NOT NOTICE IT AND ENDED UP IN THE HOSPITAL THAT DAY. SHE STATED THAT SHE HAD GONE BACK TO THE HOSPITAL FEW DAYS AFTER DUE TO KETONES AND SHE BELIEVED IT WAS BECAUSE SHE HAD A VERY BIG RED SWOLLEN LEG DUE TO THE FALL. REPORTEDLY, THE TUBING CONNECTOR ON THE INFUSION SET WAS BROKE AND HIS WIFE WAS HOSPITALIZED 6 WEEKS DUE TO KETONES AND HAS BEEN DISCHARGED. HOWEVER, HIS WIFE WAS STILL WEAK, AND SHE WAS STILL A BIT CONFUSED BECAUSE SHE WAS RECENTLY DISCHARGED. PRESENTLY, SHE WAS ON MANUAL INJECTIONS AS REPORTED BY HER HUSBAND. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 11662550 ↗
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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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