Silhouette® Paradigm® MMT-368Recalls & 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 05705244008434), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ON 30-OCT-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT'S MOTHER REPORTED, THE TUBING DETACHED FROM THE SITE AND DETACHMENT OCCURRED AT QUICK RELEASE ON THE DAY OF THIS REPORT ((B)(6) 2018). THE SET CAME OUT OF THE PATIENT'S BODY WHILE SHE WAS SLEEPING. ON (B)(6) 2018, AT 12:47 PM, THE PATIENT CHANGED THE INFUSION SET. THE SITE LOCATION WAS AT THE OUTER PART OF RIGHT THIGH AND THE PUMP WAS CLIPPED TO PATIENT'S RIGHT-SIDE WAIST BAND. THE PATIENT WAS USING AN INFUSION SET WITH SERIAL NO. (B)(4). THE INFUSION SET WAS BEING USED FOR 4 DAYS. THE INFUSIONS WERE STORED AT ROOM TEMPERATURE. THE PATIENT WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WASN'T DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8172858 ↗
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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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