Perfusion Pack (UDI 00803622136573)Recalls & reported problems
Data updated Oct 13, 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 00803622136573), received between Feb 10, 2021 and Apr 21, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disconnection3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2022Disconnection; Disconnection
LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING A ECLS SUPPORT, TWO DIFFERENT EVENTS OF LINE DISCONNECTION OCCURRED ON THE SAME PATIENT WITH THE SAME TUBING SET. THE FIRST DISCONNECTION (PRESENT REPORT) OCCURRED SHORTLY AFTER INITIATION ON (B)(6) 2022 FROM THE OUTLET OF A COMPETITOR OXYGENATOR. THE TUBING SET HAD BEEN ASSEMBLED DRY AS A STANDBY SETUP. THE TUBING WAS PUSHED FULLY ONTO THE OXYGENATOR OUTLET CONNECTOR AND TIE BANDED. THE SPECIFIC TIE GUN USED WAS NOT RECORDED. LINE PRESSURE WAS APPX 300MM HG. THE LINE WAS NOT UNDER TENSION. SUPPORT WAS RESUMED IN 1-2 MINUTES AFTER DE-AIRING AND RECONNECTING THE CIRCUIT. THE SECOND DISCONNECTION OCCURRED ON (B)(6) 2022 AND IS BEING REPORTED AS A SEPARATED MEDWATCH. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14166759 ↗MalfunctionApr 21, 2022Disconnection; Disconnection
LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING A ECLS SUPPORT, TWO DIFFERENT EVENTS OF LINE DISCONNECTION OCCURRED ON THE SAME PATIENT WITH THE SAME TUBING SET. THE FIRST DISCONNECTION IS BEING REPORTED AS A SEPARATED MEDWATCH. THE SECOND DISCONNECTION (PRESENT REPORT) OCCURRED ON (B)(6) 2022 FROM A 3/8 CONNECTOR THAT WAS PLACED IN THE ARTERIAL LINE AS PART OF AN OXYGENATOR CHANGE-OUT. THE CONNECTOR WAS A COMPETITOR DEVICE. NO TIE BANDS WERE PLACED ON THE CONNECTION AND THE TUBING WAS FULLY INSERTED OVER ALL BARBS. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14166756 ↗MalfunctionFeb 10, 2021Disconnection; Disconnection
LIVANOVA USA INC. HAS RECEIVED A REPORT THAT, DURING SUPPORT, THE TUBING DISCONNECTED FROM THE OUTLET OF THE OXYGENATOR (MAQUET QUADROX). THE PATIENT WAS ADMINISTERED OF BLOOD BANK. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11306542 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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