Silhouette ParadigmRecalls & reported problems across all models

We found 12 models of Silhouette Paradigm by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2017 and Sep 26, 2026 — classified as 3 deaths, 19 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (63 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 Silhouette Paradigm problems

Silhouette Paradigm models

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

• Silhouette® Paradigm® MMT-381

  Set, Administration, Intravascular
  1 death45 reports
• Silhouette® Paradigm® MMT-378

  Set, Administration, Intravascular
  1 death28 reports
• Silhouette® Paradigm® MMT-382

  Set, Administration, Intravascular
  17 reports
• Silhouette® Paradigm® MMT-377

  Set, Administration, Intravascular
  1 death8 reports
• Silhouette® Paradigm® MMT-383

  Set, Administration, Intravascular
  3 reports
• Silhouette® Paradigm® MMT-381600

  Set, Administration, Intravascular
  2 reports
• Silhouette® Paradigm® MMT-384

  Set, Administration, Intravascular
  2 reports
• Silhouette® Paradigm® MMT-382600

  Set, Administration, Intravascular
  2 reports
• Silhouette® Paradigm® MMT-368600

  Set, Administration, Intravascular
  1 report
• Silhouette® Paradigm® MMT-368

  Set, Administration, Intravascular
  1 report
• Silhouette® Paradigm® MMT-378600

  Set, Administration, Intravascular
  1 report
• Silhouette® Paradigm® MMT-377600

  Set, Administration, Intravascular
  1 report

Recent Silhouette Paradigm adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Device Handling Problem

  Patient problems: Hyperglycemia

  MAUDE report 50907573 ↗
• InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperglycemia

  MAUDE report 50629994 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced high blood glucose event on (b)(6) 2026 and was treated with insulin pen.

  Patient problems: Hyperglycemia

  MAUDE report 50269860 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had high blood glucose and treated with insulin pump on (b)(6)2026

  Patient problems: Hyperglycemia

  MAUDE report 50189858 ↗
• MalfunctionAug 6, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156655 ↗
• DeathJun 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE AND WAS LATER DECEASED DUE TO HEART CONDITION AND HYPOTENSION ADRENAL INSUFFICIENCY ON (B)(6) 2020.

  Patient problems: Hypoglycemia

  MAUDE report 25495546 ↗
• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482683 ↗
• InjuryApr 13, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT FACED HIGH BLOOD GLUCOSE WHICH GOT TREATED WITH BOLUS. THE BLOOD GLUCOSE WAS BEEN HIGH FOR 4 HOURS.

  Patient problems: Hyperglycemia

  MAUDE report 24855941 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT FACED CANNULA ISSUE ON (B)(6) 2026. THE INFUSION SET CANNULA WAS BENT AND THE PATIENT EXPERIENCED PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24731211 ↗
• MalfunctionMar 30, 2026Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT FACED CANNULA ISSUE ON (B)(6) 2026. THE INFUSION SET CANNULA WAS BENT AND THE PATIENT EXPERIENCED PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24730266 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4) EVENT COUNTRY IN SWITZERLAND. IT WAS REPORTED THAT THE THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE

  Patient problems: Pain

  MAUDE report 24728111 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4) EVENT COUNTRY IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24726215 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4). EVENT COUNTRY IN THE SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24725958 ↗
• MalfunctionMar 30, 2026Partial Blockage

  REFERENCE NUMBER (B)(4). EVENT COUNTRY IN THE SWITZERLAND. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTION SITE BECAUSE THE INFUSION SET CANNULA BECAME BENT WITHIN A FEW MINUTES OF USE ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 24725938 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE CANNULA SITE DURING PHYSICAL ACTIVITY ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701339 ↗

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