NA ATLS24Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169108363), received between Sep 2, 2024 and Sep 29, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak; Noise, Audible

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50928840 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AUTOLOG ONE SOURCE PACKS, IT WAS REPORTED THAT THERE WERE ONLY 2 LAYERS OF PACKAGING WHEN THERE SHOULD BE 3 LAYERS TO GUARANTEE STERILIZATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE 14 PRODUCTS. ALL PACKED IN THE WRONG WAY SO THEY WERE NOT STERILE UPON ARRIVAL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THESE WHERE ALREADY REPLACED AND SHIPPED TO CUSTOMER, HOWEVER THE NEW PRODUCTS THAT WHERE SENT AS REPLACEMENTS WERE ALSO SENT WITH TWO LAYERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108713 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  "MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AUTOLOG ONE SOURCE PACKS, IT WAS REPORTED THAT THERE WERE ONLY 2 LAYERS OF PACKAGING WHEN THERE SHOULD BE 3 LAYERS TO GUARANTEE STERLIZATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WHERE 14 PRODUCTS. ALL PACKED IN THE WRONG WAY SO THEY WERE NOT STERILE UPON ARRIVAL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THESE WHERE ALREADY REPLACED AND SHIPPED TO CUSTOMER. BUT THE NEW PRODUCTS THAT WHERE SENT AS REPLACEMENTS WAS ALSO SENT WITH TWO LAYERS SO WE ARE BACK TO SQUARE ONE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108695 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AUTOLOG ONE SOURCE PACKS, IT WAS REPORTED THAT THERE WERE ONLY 2 LAYERS OF PACKAGING WHEN THERE SHOULD BE 3 LAYERS TO GUARANTEE STERLIZATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE 14 PRODUCTS. ALL PACKED IN THE WRONG WAY SO THEY WERE NOT STERILE UPON ARRIVAL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THESE WHERE ALREADY REPLACED AND SHIPPED TO CUSTOMER, HOWEVER THE NEW PRODUCTS THAT WHERE SENT AS REPLACEMENTS WERE ALSO SENT WITH TWO LAYERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108220 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AUTOLOG ONE SOURCE PACKS, IT WAS REPORTED THAT THERE WERE ONLY 2 LAYERS OF PACKAGING WHEN THERE SHOULD BE 3 LAYERS TO GUARANTEE STERLIZATION. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WHERE 14 PRODUCTS. ALL PACKED IN THE WRONG WAY SO THEY WERE NOT STERILE UPON ARRIVAL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THESE WHERE ALREADY REPLACED AND SHIPPED TO CUSTOMER. BUT THE NEW PRODUCTS THAT WERE SENT AS REPLACEMENTS WAS ALSO SENT WITH TWO LAYERS SO WE ARE BACK TO SQUARE ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108208 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT THE BOWL WAS LEAKING AND THERE WAS AIR IN THE LINE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107324 ↗
• MalfunctionDec 17, 2025Device Alarm System; Fluid/Blood Leak; Air/Gas in Device; Device Alarm System; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT THE BOWL WAS LEAKING AFTER THE SURGERY HAD STARTED. IT OVERFLOWED INTO THE TRAP AND CONTINUED TO OVERFLOW. THE MACHINE DISPLAYED A WARNING STATING THAT ¿THE TUBE HAS AIR". ONCE THE LEAK WAS IDENTIFIED, THE CIRCUIT WAS REPLACED WITH A PRODUCT FROM THE SAME BATCH, AND NO ISSUES WERE OBSERVED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23825400 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK AND AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT PATIENT BLOOD WAS COLLECTED DURING THE CASE AND THE CUSTOMER ATTEMPTED TO PROCESS THE BLOOD HOWEVER THE AUTOLOG IQ INSTRUMENT FAILED TO DRAW THE BLOOD FROM THE RESERVOIR. THE WASH LINES WERE OPEN AND THE RESERVOIR CLAMP WAS OPEN. THE DEVICE AND INSTRUMENT WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE COULD BE WHERE THE RED STRIPE WAS POSITIONED IN THE FLUID SENSOR, IT WAS OBSCURING THE OPTICAL SENSOR. THE CUSTOMER FELT IT WAS MORE LIKELY A DISPOSABLE ISSUE RATHER THAN AN INSTRUMENT ISSUE. THERE IS VARIATION WITH WHERE THE RED STRIPE IS POSITIONED AND OFTEN THIS TUBE NEEDS TO BE MANEUVERING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THEY MAY HAVE WORKED OUT WHAT THE ISSUE WAS AS THIS DEVICE HAS HAD SIMILAR ISSUES SINCE. IT SEEMED THAT THE TIGHTENING SPRING THAT CAUSED THE OCCLUSION ARM TO CLAMP UP AGAINST THE TUBING IN THE PUMP RACEWAY WAS NOT STRONG ENOUGH TO CAUSE ADEQUATE PRESSURE TO MAINTAIN OCCLUSION. THEREFORE, AS THE PUMP WAS TURNING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529046 ↗
• MalfunctionJun 5, 2025Device Alarm System; Break; Device Alarm System; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT THE CENTRIFUGAL BOWL WAS BROKEN WHEN USING THE AUTOLOG. THE ANESTHESIOLOGIST FOUND THAT THE PLACE WHERE THE BOWL WAS INSERTED WAS RUSTY, IMPLYING THAT THE INSTRUMENT DAMAGED THE DISPOSABLE. THE DEVICE WAS USED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148495 ↗
• MalfunctionJan 21, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT ONCE THE RED BLOOD CELLS WERE RESCUED AND AFTER THE START OF THE TRANSFUSION, THE EQUIPMENT USED FOR THE TRANSFUSION SHOWED CLOTS IN THE FILTER, THIS SITUATION WAS REPEATED SEVERAL TIMES WITH DIFFERENT TRANSFUSION EQUIPMENT, THE CUSTOMER CONSIDERED THAT THE SITUATION DERIVED FROM THE RESCUED BLOOD COMPONENTS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.   IT WAS ALSO REPORTED THAT 3875 MILLILITERS WERE PROCESSED, OF WHICH 1785 ML WAS RECOVERED, FOUR UNITS OF RED BLOOD CELLS WERE WASHED WITH A TOTAL VOLUME OF 1160 ML, 6 BAGS OF 1000 ML WAS USED TO WASH THE BOWL, AND 800 MILLILITER'S OF HEPARINIZED SOLUTION IN TOTAL. THE SURGICAL TIME WAS SIX HOURS APPROXIMATELY. DURING THIS SURGERY SEVEN UNITS OF FRESH FROZEN PLASMA WERE TRANSFUSED AND ONE PLATELET APHERESIS WAS PERFORMED. THE COLD ISCHEMIA TIME WAS 6 HOURS 41 MINUTES AND THE WARM ISCHEMIA TIME WAS 33 MINUTES. THE PATIENT WAS UNDERGOING A LIVER TRANSPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197068 ↗
• MalfunctionJan 15, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, THE CUSTOMER REPORTED THAT THERE WAS A LEAK COMING FROM THE CENTRIFUGE WHEN THE INSTRUMENT WAS TESTED. THE CUSTOMER STATED THAT THE CENTRIFUGAL BOWL WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO VISUAL, AUDITORY OR PERFORMANCE ABNORMALITIES. THE LEAK OCCURRED WHEN COMPLETING THE CIRCUIT. THE CONTAINER OR PIPING HAD NOT BEEN REPLACED/REINSTALLED/REPLACED. THE BOWL WAS FULL, BUT THE CIRCUIT WAS NO T FILLED, AS IT WAS LEAKING. AN ERROR WARNING MESSAGE DID NOT APPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158686 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING PRIMING OF THIS AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT THE KIT WAS CONNECTED TO THE INSTRUMENT NORMALLY. AFTER PRIMING, THE BOWL STARTED LEAKING SALINE. THERE WAS NO BLOOD LOSS AS THE LEAKAGE WAS NOTICED BEFORE THE MACHINE WAS USED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WAS NO DAMAGE MADE TO THE BOWL BY THEIR TEAM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO VISUAL, AUDIBLE OR PERFORMANCE ABNORMALITIES. THE LEAK/SPILL ON THE DISPOSABLE SPECIFICALLY OCCURRED AT BOWL. THE FLUID LEVEL OF THE RESERVOIR, HOLDING, SALINE AND WASTE BAG AT THE TIME OF THE ISSUE IS NOT KNOWN. THE MACHINE SHOWED THE ALARM MESSAGE JUST WHEN THE SALINE RAN IN THE BOWL. AFTER THE ERROR WARNING MESSAGE, THE KIT WAS CHANGED. THE MACHINE WORKED WELL AFTER THE KIT WAS CHANGED. THERE WAS NO BLOOD LOSS AS A RESULT OF THIS LEAK. THERE WAS NO TRANSFUSION REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784811 ↗
• MalfunctionNov 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT DURING BLOOD WASHING, A LOT OF RED BLOOD CELLS WERE EJECTED TO THE WASTE BAG. THE MAINTENANCE OF THE AUTOLOG IQ WAS DONE WITHOUT ISSUE, SO THE CUSTOMER THOUGHT THAT MAYBE THE TUBING OF THE ONE SOURCE PACK WAS FAULTY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED IN THE ONE SOURCE PACK. THERE WERE NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. THE ISSUE OCCURRED DURING THE FIRST WASHING CYCLE. THE CUSTOMER REINSTALLED THE TUBING, NOTHING CHANGED FOR THE NEXT WASHING CYCLE. THE CUSTOMER STATED THAT THEY SAW THAT, THE COLOR OF THE WASTE BAG WAS MORE RED THAN USUAL AND THOUGHT THAT MORE RED CELLS HAD GONE IN THE WASTE BAG. THERE WAS NO ERROR MESSAGE. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20743874 ↗
• MalfunctionNov 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THE DEVICE SUFFERED A FRACTURE IN ONE OF ITS COMPONENTS DURING SURGERY. THE DEFECTIVE COMPONENT THAT FRACTURED WAS THE BELL/CENTRIFUGAL BOWL THAT PERFORMS THE CENTRIFUGAL WASHING, CAUSING THE BLOOD TO BE DISLODGED. THE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK OCCURRED DURING THE FILLING OF THE CENTRIFUGAL BOWL. IT SEEMED THAT ALL THE BLOOD WAS BEING DISCARDED TO THE WASTE BAG. THE PERFUSIONIST TRIED TO CHECK THAT IT WAS IN CORRECT POSITION AND THEN THE BLOOD BEGAN TO LEAK OUT OF THE CENTRIFUGAL BOWL BECAUSE IT WAS BROKEN. THE BOWL WAS RE-SEATED. THERE WERE NO CHANGES NOTED. THERE WAS 800 ML OF BLOOD IN THE RESERVOIR, AND IT WAS FIRST CYCLE. THERE WAS APPROXIMATELY 800 ML OF BLOOD LOST WITH 25% OF HCT FROM THE BYPASS MACHINE AND ANOTHER 300 ML FROM THE PATIENT BLEEDING. THERE WAS NO ERROR WARNING MESSAGE THAT APPEARED. THE CUSTOMER DOES NOT KNOW FOR SURE IF A TRANSFUSION WILL BE REQUIRED. IT IS PRESUMED THAT THE PATIENT MIGHT RECEIVE SOME BLOOD IN THE ICU. MEDTRONIC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20724677 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT WHILE PURGING, A LEAK WAS DETECTED. THE ONE SOURCE PACK WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED ON THE INSTRUMENT OR THE ONE SOURCE PACK. THE WATER LEAK WAS THE ONLY ABNORMALITY NOTED. THE LEAK OCCURRED 'IN THE BELL'/CENTRIFUGAL BOWL. THE LEAK OCCURRED WHILE PURGING THE SYSTEM BEFORE THE SURGERY. INFORMATION ON THE FILL (FLUID) LEVEL OF THE RESERVOIR, HOLDING, SALINE AND WASTE BAG AT THE TIME OF THE ISSUE COULD NOT BE PROVIDED. NO ERROR/WARNING MESSAGE APPEARED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT PURGING OF THE EQUIPMENT WAS DONE AUTOMATICALLY WHEN PERFORMING THE SELF-CHECK AND THE SUCTION LINE WAS PURGED WITH 200ML OF SALINE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723770 ↗
• MalfunctionSep 23, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS AUTOLOG ONE SOURCE PACK HAD A LEAKING BOWL AND AIR IN LINE ISSUE, SALINE LEAKED THROUGH THE COMPARTMENT. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280517 ↗
• MalfunctionSep 23, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF 2 AUTOLOG ONE SOURCE PACKS, IT WAS REPORTED THAT FOR PLI 10: CUSTOMER NOTICED A LEAKAGE THROUGH THE BOWL AND IN PLI 20: CUSTOMER OBSERVED THAT THE DEVICE FILLED, BUT FOUND AIR ON THE LINE, DURING CHECK, CUSTOMER OBSERVED LEAKAGE BY THE BOWL. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE. THE ONLY ABNORMALITY, IDENTIFIED BY THE CUSTOMER, WAS THE IDENTIFICATION OF LIQUID COMING OUT FROM UNDER THE EQUIPMENT. THE LEAK OCCURRED DURING ASSEMBLY OF THE DEVICE. THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED BEFORE THE EQUIPMENT WAS MADE AVAILABLE FOR THE SURGICAL PROCEDURE. THEREWAS NO CONTACT WITH FLUIDS. THERE WERE NO ERROR WARNING MESSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279611 ↗
• MalfunctionSep 2, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT AIR WAS SEEN IN THE LINE, AND CUSTOMER ALSO NOTICED A LEAK BY THE BOWL. CUSTOMER WAS ABLE TO READ THE DISPOSABLE EXCHANGE MATERIAL AND RESOLVED THE PROBLEM. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118191 ↗