Custom Perfusion SystemRecalls & reported problems across all models
Medtronic, Inc. · 61 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Custom Perfusion System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 5
We found 61 models of Custom Perfusion System by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Apr 23, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
5 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Custom Perfusion System 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.
- Dec 12, 2022Open, Classified
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Z-1028-2023 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 12, 2022Open, Classified
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Z-1027-2023 · Root cause: Process change control · names 4 of these models · Recall details · FDA record ↗
- Jan 3, 2018Terminated
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Z-0535-2018 · Root cause: Component change control · Recall details · FDA record ↗
- Nov 16, 2016Terminated
Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.
Z-0826-2017 · Root cause: Process control · names 11 of these models · Recall details · FDA record ↗
- Feb 4, 2016Terminated
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.
Z-1023-2016 · Root cause: Component design/selection · names 48 of these models · Recall details · FDA record ↗
Most reported Custom Perfusion System problems
Device problems
- Fluid/Blood Leak5
- Material Separation3
- Material Puncture/Hole2
- Crack1
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Custom Perfusion System models
61 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Custom Perfusion System HY8L55R5PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
- Custom Perfusion System BB6U40R11PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls1 report
- Custom Perfusion System HY6Y19R5PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls0 reports
- Custom Perfusion System BB8U95R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls0 reports
- Custom Perfusion System BB8T05R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls0 reports
- Custom Perfusion System CB4W67R15PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall1 report
- Custom Perfusion System TL5V70R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System TL5U46R2PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB2E68R6PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System TL5V78R4PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System TL5U45R3PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB6M65RPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System TL7C52R3PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System 7T88RPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY2K67R10PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System 6A30R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY1C33R26PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY0Z20R21PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB5Z97R14PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY2800R37PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY2J36R13PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB7J04R9PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY2J35R12PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY7N09R8PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8G43R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB7M84R3PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB7Y32R12PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB5G58R30PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB5347R11PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY2S09R13PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8A69R8PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB6U81R2PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY6N63R10PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8M48R2PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY6W12R9PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB7F11R9PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB7Z44R6PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY8M65R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB2W45R17PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8C09R4PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY7Z58R6PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System CB7U79R9PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY7X48R8PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8P69RPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB7N95R16PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY8N22R6PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY8R55RPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY0W84R28PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB4Z62R17PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8B13R6PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY1W12R28PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8T80R1PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8S23RPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8J66R10PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY5V41R17PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System HY7V67R8PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB3X42R13PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8N94R4PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB8S74R2PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 recall0 reports
- Custom Perfusion System BB0H30R23PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 reports
- Custom Perfusion System HY7W83R4PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE1 report
Recent Custom Perfusion System adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE QUICK CONNECTOR ON THE ARTERIAL LINE WAS LOOSE/SEPARATED. THE LOOSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THERE WAS MINIMAL BLOOD LOSS THAT WAS ESTIMATED AT 100ML. THERE WAS NO TRANSFUSION REQUIRED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE COMPONENT SEPARATED DURING THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19163104 ↗MalfunctionApr 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE LOCATION IN WHICH THE TUBING WAS CONNECTED TO THE LUER PORT. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141549 ↗MalfunctionJul 18, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER WAS PRIMING THE CIRCUIT. WHEN FLUID ENTERED THE CONE DURING GRAVITY PRIMING, IT BEGAN TO LEAK FROM WHAT APPEARED TO BE A CRACK AT THE TOP OF THE INLET CONNECTOR NEAR WHERE THE TUBING WAS CONNECTED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE PACKAGING OF THE PACK WAS INTACT WITH NO DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17341434 ↗MalfunctionJul 5, 2023Material Puncture/Hole; Material Puncture/Hole
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO CUSTOM TUBING PACKS, THE 1/4 CP TUBING RUPTURED DURING THE CASE. BOTH CUSTOM PACKS WERE USED DURING THE SAME PROCEDURE ON THE SAME PATIENT. THE CARDIOPLEGIA WAS REPLACED TO COMPLETE THE CASE. THERE WAS 50 CC OF BLOOD LOSS AS A RESULT OF THE RUPTURE. NO BLOOD TRANSFUSION WAS REQUIRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17254294 ↗MalfunctionJun 20, 2023Material Separation; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CARDIOPLEGIA LINE SPLIT. THE CARDIOPLEGIA TUBING WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. THERE WAS NO DAMAGE TO THE PACKAGING. THE OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163210 ↗MalfunctionJun 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS CUSTOM TUBING PACK THERE WAS A LEAK NOTED COMING FROM THE CARDIOPLEGIA LINE. APPROXIMATELY 5 CC OF BLOOD WAS LOST DUE TO THE LEAK. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162872 ↗MalfunctionJun 20, 2023Material Separation; Material Separation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK IT WAS NOTED THAT THERE WAS A SPLIT IN THE CARDIOPLEGIA TUBING. THE PACK WILL BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17161052 ↗MalfunctionJun 8, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACK, IT WAS REPORTED THAT THE CUSTOMER WAS PRIMING THE CIRCUIT PRIOR TO PATIENT ENTERING THE ROOM AND FLUID LEAK WAS FOUND COMING FROM THE PUMP HEAD DURING GRAVITY PRIME. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17085301 ↗MalfunctionJan 4, 2017Misassembled; Misassembled
MEDTRONIC RECEIVED INFORMATION THAT AFTER INITIATING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT USING A MEDTRONIC TUBING PACK, THE CUSTOMER OBSERVED VERY LOW PATIENT BLOOD PRESSURE. AFTER APPROXIMATELY SEVEN MINUTES, THE CUSTOMER REALIZED THE RED AND BLUE LABELS ON THE TUBING OUTSIDE OF THE STERILE FIELD, DID NOT COINCIDE WITH THE RED BLUE LABELS ON THE INSIDE OF THE STERILE FIELD THAT WERE CONNECTED TO THE ARTERIAL AND VENOUS CANNULA. THE LINES WERE CLAMPED, TUBING CUT, AND CIRCUIT RE-CONNECTED THE CORRECT WAY. PATIENT BLOOD PRESSURE RETURNED TO NORMAL AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS NOT EXPECTED TO RETURN TO MEDTRONIC FOR ANALYSIS. DURING PRIMING OF THIS CIRCUIT, THE CUSTOMER OBSERVED A LEAK FROM THE 3/8 INCH CONNECTOR WITH BLUE TAPE. THE CUSTOMER CUT THE PIECE TO REPLACE IT WITH ANOTHER CONNECTOR. WHILE THE LEAKING CONNECTOR HAD BLUE TAPE PRESENT, THE REPLACEMENT CONNECTOR DID NOT. AFTER THE CONNECTOR WAS REPLACED, PRIMING WAS COMPLETED AND ECMO INITIATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6221811 ↗
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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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