Silhouette® Paradigm® MMT-383Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244008892), received between Apr 17, 2020 and Oct 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Infusion or Flow Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288346 ↗MalfunctionJun 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE INFUSION SET'S TUBING WAS DETACHED AT THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION HAD BEEN USED FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. MOREOVER, THE PATIENT WAS UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10108665 ↗MalfunctionApr 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP, HE NOTICED THAT HIS INFUSION SET'S TUBING HAD DISCONNECTED AT THE SITE WHILE SLEEPING. THE SITE LOCATION WAS HIS ABDOMEN AND THIGH AND THE PUMP WAS LOCATED 3 INCHES AWAY FROM THE SITE. THE INFUSION HAD BEEN USED FOR ONE NIGHT AND THEY WERE STORED IN THE HOME. THEY WERE UNSURE OF ANY STRESS OR PULL ON THE TUBING AND WAS THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HIS BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9971081 ↗
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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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