NA 2450Recalls & reported problems
Atrium Medical Corporation · BLOOD BAG, ATS SELF-FILLING · Class 2
- 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 00650862124507), received between Aug 6, 2018 and Feb 11, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Open or Close1
- Insufficient Flow or Under Infusion1
- Self-Activation or Keying1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2019Self-Activation or Keying
AUTO TRANSFUSION BLOOD BAG WAS ALREADY ACTIVATED OR ¿SPRUNG¿.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8328795 ↗MalfunctionAug 6, 2018Insufficient Flow or Under Infusion
REPORT STATED THAT AN ATS BLOOD BAG COULD NOT BE ACTIVATED, UNABLE TO MANUALLY EXTRACT MORE THAN 150 ML OF BLOOD AND COULD ONLY TRANSFUSE LIMITED AMOUNT OF BLOOD BACK INTO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7754098 ↗MalfunctionAug 6, 2018Difficult to Open or Close
REPORT RECEIVED STATED THAT THE BLOOD BAG WOULD NOT OPEN, IT HAD TO BE PRYED OPEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7754090 ↗
Other APPARATUS, AUTOTRANSFUSION devices
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- EXPRESS 4050-100NAtrium Medical Corporation · APPARATUS, AUTOTRANSFUSION2 recalls2 reports
- NA ATL2001Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 death79 reports
- autoLog IQ™ ATLGIQMedtronic, Inc. · APPARATUS, AUTOTRANSFUSION58 reports
- NA BTC93Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall2 reports
- OCEAN 2050-000Atrium Medical Corporation · Apparatus, Autotransfusion1 recall2 reports
- NA BTC98Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall0 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-125Haemonetics Corporation · Apparatus, Autotransfusion47 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.