Silhouette® MMT-369Recalls & reported problems
Unomedical A/S · Single use infusion cannula for subcutaneous infusion. The infusion cannula must be used as described in the Instruction for Use. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244005136), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Missing Value Reason” (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
- Missing Value Reason1
Patient problems
- Brain Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2018Missing Value Reason; Missing Value Reason
(B)(4). THE PATIENT CALLED IN REPORTING THAT EXPERIENCED A TRAUMATIC BRAIN INJURY AND WAS IN THE ICU DUE TO THIS EVENT, THERE WAS NO INFORMATION OF WHAT COULD HAVE CAUSED THIS EVENT, NO SELF MALFUNCTION OR FAILURE IS MENTIONED IN THE COMPLAINT, ALSO NO SYMPTOMS OF DKA OR LOW BG LEVELS THAT COULD RELATE TO PATIENTS BRAIN INJURY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Brain Injury
MAUDE report 7163313 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page