Perfusion PackRecalls & reported problems across all models
Livanova USA, Inc. · 77 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 95
- Deaths reported
- 3
- Injuries reported
- 11
- Recalls
- 2
We found 77 models of Perfusion Pack by Livanova USA, Inc. in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2016 and Sep 30, 2026 — classified as 3 deaths, 11 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Disconnection” (35 reports).
2 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Perfusion Pack recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 3, 2019Terminated
Perfusion tubing pack was packaged with the incorrect cuvette.
Z-1389-2020 · Root cause: Employee error · Recall details · FDA record ↗
- Dec 19, 2017Terminated
The product is labeled with the incorrect expiration date.
Z-0664-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported Perfusion Pack problems
Device problems
- Disconnection35
- Misassembled12
- Fluid/Blood Leak10
- Material Fragmentation5
- Material Split, Cut or Torn5
- Component Misassembled3
- Device Misassembled During Manufacturing /Shipping3
- Material Discolored3
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient16
- No Patient Involvement16
- Insufficient Information6
- Death5
- Hypovolemia5
- Blood Loss2
- Stroke/CVA2
Perfusion Pack models
77 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall0 reports
- 1 recall0 reports
- 4 reports
- 3 reports
- 3 reports
- 3 reports
- 3 reports
- 2 reports
- 2 deaths2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 2 reports
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 death1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
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- 1 report
- 1 report
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- 1 report
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- 1 report
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- 1 report
- 1 report
- 1 report
Recent Perfusion Pack adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow
Upon initiation of bypass, it was visualized that the blood draining from the venous line was collecting in the sock filter of the reservoir rather than draining into the main body of the reservoir. The surgeon was notified. This hold-up resolved as the bypass run continued.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945167 ↗InjuryJun 12, 2026Unexpected Therapeutic Results
SORIN GROUP ITALIA RECEIVED A REPORT OF INSPIRE 8F OXYGENATOR PERFORMANCE PROBLEMS, UPON INITIATION OF BY-PASS. IN DETAILS, VALUES OF PARTIAL PRESSURE OF OXYGEN (PO2) WAS 47 MMHG WITH FI02 OF 100% AND GAS SWEEP OF 2.5L/MIN. A SECOND OXYGENATOR WAS PLACED IN TANDEM WITH THE INVOLVED ONE WITHOUT THE NEED TO REMOVE THE PATIENT FROM BY-PASS. ANESTHETIST SUPPORTED THE PATIENT WITH ADDITIONAL FI02 AND VENTILATION SUPPORT. AFTER THE SECOND OXYGENATOR WAS PLACED, PATIENT P02 WAS MEASURED AND IT WAS 583 MMHG. THERE WAS NO PATIENT INJURY. BASED ON MEDICAL ASSESSMENT, THE USE OF TWO OXYGENATORS IN TANDEM HAS BEEN CONSIDERED AN ADDITIONAL INTERVENTION TO PRECLUDE SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481877 ↗InjuryJun 12, 2026Unexpected Therapeutic Results
SORIN GROUP ITALIA RECEIVED A REPORT OF INSPIRE 8F OXYGENATOR PERFORMANCE PROBLEMS, UPON INITIATION OF BY-PASS. IN DETAILS, VALUES OF PARTIAL PRESSURE OF OXYGEN (PO2) WAS 47 MMHG WITH FI02 OF 100% AND GAS SWEEP OF 2.5L/MIN. A SECOND OXYGENATOR WAS PLACED IN TANDEM WITH THE INVOLVED ONE WITHOUT THE NEED TO REMOVE THE PATIENT FROM BY-PASS. ANESTHETIST SUPPORTED THE PATIENT WITH ADDITIONAL FI02 AND VENTILATION SUPPORT. AFTER THE SECOND OXYGENATOR WAS PLACED, PATIENT P02 WAS MEASURED AND IT WAS 583 MMHG. THERE WAS NO PATIENT INJURY. BASED ON MEDICAL ASSESSMENT, THE USE OF TWO OXYGENATORS IN TANDEM HAS BEEN CONSIDERED AN ADDITIONAL INTERVENTION TO PRECLUDE SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481870 ↗MalfunctionJan 14, 2026Component Misassembled
LIVANOVA USA RECEIVED A REPORT OF A PERFUSION TUBING PACK WHICH HAD THE COLOURED CLAMPS OF CARDIOPLEGIA DELIVERY LINES INVERTED. RED CLAMP WAS FOUND ON WHITE CLAMP LINE AND VICE VERSA. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24065413 ↗MalfunctionDec 22, 2025Disconnection; Disconnection
LIVANOVA USA RECEIVED REPORT ABOUT DISCONNECTION IN THE ARTERIAL LINE WHERE THE 1/8TH TUBING CONNECTS TO MALE LUER OF A PERFUSION TUBING SYSTEM (PTS). PERFUSIONIST STOPPED BYPASS FOR APPROXIMATELY THREE MINUTES TO FIX THE PROBLEM. PROCEDURE WAS THEN RESUMED WITHOUT NO COMPLICATIONS. REPORTEDLY, PATIENT DID NOT HAVE ANY CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863605 ↗MalfunctionDec 11, 2025Pumping Problem; Pumping Problem
SORIN GROUP ITALIA RECEIVED A REPORT OF A REVOLUTION PUMP WHICH COULD NOT PROVIDE PROPER FLOW WHEN INCREASING ROUNDS PER MINUTES (RPMS), AND LOW PRESSURE WAS HIGHLIGHTED AT INLET PUMP LINE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776508 ↗MalfunctionNov 14, 2025Disconnection; Disconnection
LIVANOVA USA INC. RECEIVED A REPORT OF A VENOUS LINE BELONGING TO PERFUSION TUBING SYSTEM WHICH DISCONNECTED FROM THE CIRCUIT DURING BY-PASS. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556611 ↗InjuryJul 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionJun 20, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
OXYGENATOR FAILED AS CPB WAS INITIATED. PREBYPASS O2 CHECKS WERE ALL NORMAL. BLENDER, FLOWMETER, AND OXYGEN SENSOR WERE ALL REGISTERING NORMAL O2 LEVELS. IMMEDIATELY UPON INITIATION OF BYPASS, PERFUSIONIST NOTICED DARK BLOOD WITH FIO2 SETTING AT 100%. PERFUSIONIST TRACED THE GAS FLOW LINE, NO LEAKS OR OBSTRUCTIONS WERE FOUND. PERFUSIONIST CALLED FOR BACKUP. 3 PERFUSIONISTS TROUBLESHOOTED AND COULD NOT FIND ANY ISSUES WITH GAS FLOW TO THE OXYGENATOR. IT WAS THEN DECIDED TO CHANGE OUT THE OXYGENATOR. THEY CAME OFF OF CPB FOR A FEW MINUTES WHILE ANESTHESIA VENTILATED THE PATIENT AND THEY CHANGED OUT THE OXYGENATOR. AS SOON AS BYPASS WAS RE-INITIATED, BRIGHT RED BLOOD WAS OBSERVED AND NEW OXYGENATOR WAS WORKING EFFICIENTLY. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296120 ↗MalfunctionJun 18, 2025Component Misassembled; Component Misassembled
LIVANOVA USA INC RECEIVED A REPORT THAT THE RED AN YELLOW CLAMPS (ON PAGE 4 OF ) IN A CARDIOPLEGIA CUSTOMIZED CIRCUIT WERE ASSEMBLED REVERSED WITH EXPECTED DISPOSICTION (DEFINED IN THE TECHNICAL DCOUMENTATION). THE CUSTOMER WAS ABLE TO USE THE PRODUCT. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282933 ↗InjuryDec 3, 2024Air/Gas in Device; Air/Gas in Device
LIVANOVA USA INC. RECEIVED A REPORT RELATED TO AN AIR INGRESS INTO A PERFUSION TUBING SYSTEM (PTS) PACK. IN DETAIL, CARDIOPLEGIA LINE WAS PRIMED AND FLUSHED WITH NO LEAKS NOTED WHEN OVER-PRESSURIZED WHILE IN PRIMING MODE. ONCE CROSS CLAMP WAS ON, WHILE DELIVERING THE CARDIOPLEGIA SOLUTION TO THE PATIENT, THE DELIVERY SYSTEM AND LINE FILLED WITH AIR. DELIVERY WAS THEN STOPPED AND ATTEMPTED TO FLUSH AIR TO THE FIELD. HOWEVER, MORE AIR CAME INTO DELIVERY SYSTEM. THEREFORE, CROSS CLAMP WAS REMOVED. PATIENT WAS DEFIBRILLATED AND CARDIOPLEGIA SYSTEM WAS EXCHANGED FOR NEW ONE. NEW CARDIOPLEGIA CIRCUIT WAS PRIMED AND FLUSHED TO THE FIELD. CROSS CLAMP WAS PLACED AND CARDIOPLEGIA WAS DELIVERED WITH NO AIR ISSUES.
Patient problems: Insufficient Information
MAUDE report 20830134 ↗InjuryDec 3, 2024Air/Gas in Device; Air/Gas in Device
InjuryNov 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809274 ↗MalfunctionNov 29, 2024Disconnection; Disconnection
LIVANOVA USA RECEIVED A REPORT THAT THE CARDIOPLEGIA LINE SET FELL APART AT DEL NIDO BRIDGE POST CASE. MEDICAL TEAM WAS NOT ON PUMP AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809272 ↗MalfunctionSep 26, 2024Disconnection; Disconnection
LIVANOVA USA INC. RECEIVED A REPORT RELATED TO THE DISCONNECTION OF THE Y CONNECTOR PLACED IN THE OUTLET LINE OF THE ARTERIAL FILTER. THE ISSUE OCCURRED DURING PRIMING WITH FLOW AT 6 LPM. THE LINE WAS RE-CONNECTED BY THE PERFUSIONIST AND THE CIRCUIT USED FOR THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307755 ↗
Other Livanova USA, Inc. products
All Livanova USA, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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