NA ATLS02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169108332), received between Nov 8, 2024 and Apr 23, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK IN RIGHT HEPATECTOMY SURGERY, IT WAS REPORTED THAT AT THE TIME OF EQUIPMENT PURGE THE BOWL WAS FILLED WITH WATER OUTSIDE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887958 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE OF THE AUTOLOG ONE SOURCE PACK, THE CENTRIFUGE CORE SUDDENLY RUPTURED, CAUSING MASSIVE BLOOD LOSS AND THREATENING THE PATIENT'S HEALTH. THE USE OF THE DEVICE WAS NOT SPECIFIED.NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21544637 ↗
• MalfunctionNov 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT WATER LEAKED OUT OF THE BOWL AND DRAINED OUT FROM THE AUTOLOG MACHINE TO THE FLOOR. THE DEVICE WAS 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, AND THE ONLY VISUAL ABNORMALITIES OBSERVED WAS THE LEAKAGE. THE FILL LEVEL FOR THE RESERVOIR, HOLDING, SALINE, AND WASTE BAG AT THE TIME OF THE ISSUE WAS PRIMING STAGE, MIN VOLUME. NO ERROR WARNING MESSAGE APPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804083 ↗
• MalfunctionNov 26, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A ATLS02, IT WAS REPORTED THAT IT CRACKED DURING THE WASHING PROCESS. BLOOD/WATER LEAKED OUT OF THE BOWL AND DRAIN OUT FROM THE AUTOLOG MACHINE ONTO THE FLOOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE AUDIBLE ABNORMALITIES, STRANGE AND NOISY SOUND WHEN PROCESSING. THE LEAK O CCURRED DURING THE WASH CYCLE. THE BOWL WAS RE-SEATED TO THE SAME MACHINE, THE DEVICE WAS STILL LEAKING AND THE BOWL CRACKED. THE CUSTOMER CHANGED TO A NEW SET OF CONSUMABLES. THE LEVEL OF RESERVOIR WAS 1600ML, HOLDING 200ML, SALINE 2000ML AND WASTE BAG WAS 2000ML. NO ERROR WARNING MASSAGE APPEARED. PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK WAS 300ML. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20788523 ↗
• InjuryNov 8, 2024Device Alarm System; Fluid/Blood Leak; Obstruction of Flow; Device Alarm System; Fluid/Blood Leak; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG ONE SOURCE PACK, IT WAS REPORTED THAT THE CENTRIFUGE BOWL FAILED AND BLOOD SPILLED OUTSIDE THE BOWL. CUSTOMER COULD NOT COMPLETE THE CELL SALVAGE PROCEDURE. SEE ATTACHED PHOTOS. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639231 ↗