AV1016-01 Avoset 250mL Medication Reservoir Pouch 12222-000-1016Recalls & reported problems
Eitan Medical Ltd · 250mL Medication Reservoir · Class 2
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 17290109152704), received between Jan 7, 2026 and Sep 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Leak/Splash
This complaint was reported by a customer from USA.A leakage issue was reported.The customer reported that no human harm occurred and no medical intervention was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864858 ↗MalfunctionJan 7, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987995 ↗MalfunctionJan 7, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. THE CUSTOMER REPORTED THAT NO HUMAN HARM OCCURRED. THE ONLY MEDICAL INTERVENTION DESCRIBED WAS A CASSETTE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23987994 ↗
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