NA ATLS00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169108325), received between Nov 27, 2024 and Mar 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Noise, Audible; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT DUE TO RECURRING COMPLAINTS OF LEAKS IN AUTOLOG DISPOSABLES, X MED IDENTIFIED THE NEED TO CONDUCT VIDEO TRAINING, DEMONSTRATING THE ASSEMBLY OF THE DISPOSABLE IN THE EQUIPMENT. FOR THIS, A NEW DISPOSABLE WAS USED AND ASSEMBLY PROCESS BEGAN. THE BOWL FIT INTO THE CENTRIFUGE WITHOUT MAJOR ISSUES. AFTER PRESSING THE START BUTTON FOR THE AUTO-TEST, AS PER THE EQUIPMENT MANUAL, THE CENTRIFUGE BEGAN TO SPIN, EMITTING A LOUD FRICTION NOISE. THE TEST WAS STOPPED TO CHECK THE DISPOSABLE¿S POSITIONING, WHICH WAS CORRECTLY IN PLACE. THEN THE EQUIPMENT WAS RE-STARTED TO BEGIN THE PROCESSING CYCLE, SIMULATING A SURGICAL SCENARIO. AT THIS POINT, THE DISPLAY SHOWED AIR IN THE TUBE. SEVERAL ATTEMPTS WAS MADE TO REPOSITION IT, UNTIL AN EXPERIENCED TECHNICIAN, WHO OPERATES THE EQUIPMENT DAILY AND WAS PRESENT FOR THE RECORDING, SUGGESTED A SLIGHT TWIST IN THE TUBE TO ADJUST IT. THIS WORKED, AND THE TEST PROCEEDED WITHOUT NOISE. HOWEVER, AT THE END OF THE TEST, IT WAS FOUND THAT THE DISPOSABLE HAD SIGNS OF WEAR AT THE TOP OF THE BOWL, APPARENTLY DUE TO FRICTION, BUT WITHOUT RUPTURE, AS THE TEST WAS STO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678665 ↗
• MalfunctionFeb 12, 2025Noise, Audible; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT DUE TO RECURRING COMPLAINTS OF LEAKS IN AUTOLOG DISPOSABLES, X MED IDENTIFIED THE NEED TO CONDUCT VIDEO TRAINING, DEMONSTRATING THE ASSEMBLY OF THE DISPOSABLE IN THE EQUIPMENT. FOR THIS, A NEW DISPOSABLE WAS USED AND ASSEMBLY PROCESS BEGAN. THE BOWL FIT INTO THE CENTRIFUGE WITHOUT MAJOR ISSUES. AFTER PRESSING THE START BUTTON FOR THE AUTO-TEST, AS PER THE EQUIPMENT MANUAL, THE CENTRIFUGE BEGAN TO SPIN, EMITTING A LOUD FRICTION NOISE. THE TEST WAS STOPPED TO CHECK THE DISPOSABLE¿S POSITIONING, WHICH WAS CORRECTLY IN PLACE. THEN THE EQUIPMENT WAS RE-STARTED TO BEGIN THE PROCESSING CYCLE, SIMULATING A SURGICAL SCENARIO. AT THIS POINT, THE DISPLAY SHOWED AIR IN THE TUBE. SEVERAL ATTEMPTS WAS MADE TO REPOSITION IT, UNTIL AN EXPERIENCED TECHNICIAN, WHO OPERATES THE EQUIPMENT DAILY AND WAS PRESENT FOR THE RECORDING, SUGGESTED A SLIGHT TWIST IN THE TUBE TO ADJUST IT. THIS WORKED, AND THE TEST PROCEEDED WITHOUT NOISE. HOWEVER, AT THE END OF THE TEST, IT WAS FOUND THAT THE DISPOSABLE HAD SIGNS OF WEAR AT THE TOP OF THE BOWL, APPARENTLY DUE TO FRICTION, BUT WITHOUT RUPTURE, AS THE TEST WAS STO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362605 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT WHEN THE CUSTOMER STARTED TO USE THE ONE SOURCE PACK, IT STARTED LEAKING BLOOD AT THE TOP OF THE CENTRIFUGAL BOWL. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20794614 ↗