NA ATL2001 (UDI 00673978521862)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00673978521862), received between Mar 5, 2021 and Oct 22, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K972894); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  IT WAS REPORTED THAT DURING USE OF A CUSTOM TUBING PACK, SUCTION AND ANTICOAGULANT ASSEMBLY, AN AUTOLOG WASHKIT AND AN AUTOLOG INSTRUMENT AN ERROR MESSAGE APPEARED STATING, 'THE CENTRIFUGE IS OPERATING TOO SLOWLY. PLEASE CHECK THE INSTALLATION OF THE BOWL,' AND WASHING COULD NOT BE PERFORMED. A STRANGE NOISE (METALLIC SOUND) WAS HEARD FROM THE BOWL AREA. A SALINE LEAK FROM THE BOWL WAS ALSO OBSERVED. THE CUSTOMER TURNED THE POWER OFF AND ATTEMPTED TO SETUP SEVERAL TIMES HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE DEVICE WAS REPLACED. IT IS UNCLEAR WHETHER THE PROBLEM WAS DUE TO A DEFECT IN THE DISPOSABLE OR IN THE MAIN DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO DAMAGE WAS OBSERVED VISUALLY IN THE INSTRUMENT OR THE DISPOSABLE. THE MAIN UNIT WAS POWERED OFF AND RE-ATTACHED, HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS REPEATED SEVERAL TIMES. THERE WAS APPROXIMATELY 100¿150ML OF FLUID IN THE RESERVOIR, APPROXIMATELY 300ML REMAINING IN THE 1000ML SALINE BAG, AND THE WASTE BAG WAS EMPTY. THOSE WERE APPROXIMATE VALUES. THE ERROR/WARNING MESSAGE WAS ADDRESSED BY TURNING THE POWER ON AND OFF, AND THE DISP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358416 ↗
• MalfunctionJan 15, 2025Device Alarm System; Fluid/Blood Leak; Material Deformation; Device Alarm System; Fluid/Blood Leak; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT AND AUTOLOG INSTRUMENT, IT WAS REPORTED THAT THE BLOOD LEAKED FROM THE BOWL OR BLOOD ENTERED THE HIGH-SPEED ROTATING PART AND AN ERROR APPEARED, AND THE INSTRUMENT HAD A SPEED ERROR. THE WASH KIT AND INSTRUMENT WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE WASH KIT MIGHT HAVE BEEN DAMAGED AND LEAKED. THE LEAK OCCURRED IN THE CENTRIFUGAL BOWL. THE SPECIFIC TIMING OF THE LEAK DURING THE CYCLE IS UNKNOWN. THERE WERE AUDIBLE ABNORMALITIES LIKE NOISE DURING THE ROTATION. A SPEED ERROR WAS DISPLAYED AND THE WASH KIT AND THE INSTRUMENT WERE REPLACED. THE INSTRUMENT WORKED FOR A WHILE AFTER THE REPLACEMENT BUT THE SAME ERROR MESSAGE APPEARED AGAIN. THE FILL (FLUID) LEVEL OF THE RESERVOIR, HOLDING, SALINE AND WASTE BAG AT THE TIME OF THE ISSUE ARE UNKNOWN. IT IS UNKNOWN IF THERE WAS PATIENT BLOOD LOSS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AN UNPLANNED TRANSFUSION WAS NOT PERFORMED BECAUSE OF THE BLOOD DISCARDED FROM THE BOWL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21158395 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A AUTOLOG WASH KIT, THE CUSTOMER REPORTED A BLOOD LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. NO ERROR WARNING MESSAGE APPEARED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS DAMAGE NOTED TO THE DISPOSABLE. THE WASHING BOWL LEAKED. THE LEAK OCCURRED DURING THE PROCEDURE. THE BOWL WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20721738 ↗
• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT WHILE USING THE SELF-COLLECTION INSTRUMENT, THE BLOOD IN THE CENTRIFUGAL BOWL SEEMED TO BE THIN. AFTERWARDS, THE BLOOD LEAKED COMPLETELY FROM THE BOWL AND COULD NOT BE USED. THE AUTOLOG INSTRUMENT WAS ALSO FULL OF BLOOD, THEREFORE, IT WAS REPLACED WITH A DIFFERENT INSTRUMENT URGENTLY. THE PATIENT WAS TREATED QUICKLY AND NO HEALTH DAMAGE OCCURRED. THE AUTOLOG WASH KIT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS NOT ABLE TO CONFIRM IF THERE WAS ANY DAMAGE NOTED IN THE INSTRUMENT OR THE WASH KIT. THE CUSTOMER COULD NOT TELL IF THERE WERE ANY VISUAL ABNORMALITIES, THERE WERE NO ABNORMAL SOUNDS. THE LEAK OCCURRED AT THE TIMING OF THE FIRST ENRICHMENT. THE WASH KIT WAS NOT BEEN RESEATED. WHEN THE CUSTOMER REMOVED THE WASH KIT, THE BLOOD WAS LEAKING QUITE A BIT, SO ANOTHER COMPANY'S PRODUCT WAS USED. THE CUSTOMER WAS NOT SURE WHAT THE FILL (FLUID) LEVEL OF THE RESERVOIR, HOLDING, SALINE, AND WASTE BAG WERE AT THE TIME OF THE ISSUE. AN ERROR WARNING MESSAGE DID NOT APPEAR. PAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20693732 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Smoking; Material Deformation; Noise, Audible; Fluid/Blood Leak; Smoking; Material Deformation; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT, THE CUSTOMER REPORTED AUDIBLE NOISES FROM THE BOWL AREA AND ABNORMAL ODORS. THE CUSTOMER ALSO STATED THAT THE BOWL WAS DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE NOISE STARTED SHORTLY AFTER THE START OF THE ROTATION. THE BOWL WAS BROKEN, AND THERE WAS NO DAMAGE ON THE INSTRUMENT. THE BOWL OR TUBING WAS NOT RE-SEATED. THERE WAS NO PATIENT BLOOD LOSS DUE TO REPORTED ISSUE, AND NO TRANSFUSION REQUIRED. THE MENTIONED ABNORMAL ODOR HAD A BURNING SMELL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A LEAK FROM THE BOWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585588 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT A NOISE WAS HEARD NEAR THE CENTRIFUGAL BALL JUST BEFORE A LEAK WAS OBSERVED. THE ISSUE WAS DISCOVERED DURING THE FINAL PROCESS OF COLLECTING THE PATIENT'S BLOOD. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BALL REGION IS REFERRING TO THE CENTRIFUGAL BOWL. PATIENT BLOOD LOSS WAS EXTREMELY SMALL, APPROXIMATELY 3CC OR LESS. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20576648 ↗
• InjuryDec 1, 2022Device Alarm System; Fluid/Blood Leak; Device Alarm System; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT, THE CUSTOMER REPORTED THAT AN ALARM RANG DURING AUTOMATIC CLEANING MODE OF THE INSTRUMENT. THE INSTRUMENT WAS THEN CHECKED AND IT WAS NOTED THAT THE COLLECTED BLOOD HAD LEAKED FROM AROUND THE BOWL. IT WAS CONFIRMED THAT THE BLOOD HAD ALSO FLOWED FROM UNDER THE AUTOLOG INSTRUMENT, SO THE CLEANING WAS STOPPED. ANOTHER AUTOLOG INSTRUMENT WAS AVAILABLE, SO DISPOSABLE SETTINGS WAS PERFORMED WITHOUT ANY ISSUE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT.   THE CUSTOMER STATED THAT THE SELF-BLOOD COLLECTION WAS DISCARDED (APPROXIMATELY 200 CC). THE PATIENT WAS GIVEN A BLOOD TRANSFUSION OF 576 ML. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PHYSICIAN HEARD AN ABNORMAL SOUND WHEN THE MACHINE WAS SET TO READY MODE AND THERE WAS BLOOD FOUND TO BE LEAKING FROM THE BOTTOM. THE REASON FOR BLOOD LEAK IS UNKNOWN. THE CUSTOMER REPLACED THE DISPOSABLE WASH KIT IN ADDITION TO THE INSTRUMENT AFTER THE ISSUE OCCURRED. THE PHYSICIAN ATTACHED A NEW DISPOSABLE TO ANOTHER AUTOLOG MACHINE AVAILABLE IN THE HOSPITAL AND USED IT. NO ISSUE WITH THE AUTOLOG INSTRUMENT WAS REPORTED. AROUND HALF THE AMOUNT OF BLOOD

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15892584 ↗
• InjuryMar 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THAT TWO AUTOLOG WASHKITS LEAKED BLOOD INTO THE CENTRIFUGE. THE CUSTOMER STATED THAT THERE WAS NO VISIBLE DAMAGE TO THE WASHKITS AND BLOOD SEEMED TO LEAK FROM THE TOP OF THE CENTRIFUGE. THE CUSTOMER STATED THAT THERE WAS A PUMP SPEED ERROR AND THE INSTRUMENT HAS BEEN EVALUATED AND IS FUNCTIONING APPROPRIATELY. THE INSTRUMENT WAS REPLACED, AND SECOND WASHKIT IN THIS INSTRUMENT FAILED AS WELL, BUT NO PUMP SPEED ERROR OCCURRED. BOTH DISPOSABLES HAD THE SAME LOT NUMBER. THIS ISSUE ONLY HAPPENED WITH THE AFFECTED LOT NUMBER REPORTED. WHEN THE CUSTOMER SWITCHED TO A DIFFERENT LOT NUMBER OF THE PRODUCT THERE WAS NO LEAK. WHEN THE ISSUE OCCURRED THE RESERVOIR CONTAINED ABOUT 1200 MLS OF BLOOD AND THE WASTE BAG WAS EMPTY. THE FAILURE OCCURRED WHEN ATTEMPTING TO SPIN THE FIRST BOWL. 1200 MLS OF BLOOD WAS LOST AS A RESULT OF THE ISSUE AND A TRANSFUSION WAS REQUIRED. NO ADDITIONAL PATIENT IMPACT WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11567199 ↗
• MalfunctionMar 5, 2021Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF TWO AUTOLOG WASHKITS, THE CUSTOMER REPORTED THAT THE ROLLER PUMP HEAD TUBING WAS BURST ONLY AFTER A FEW ROTATIONS. BOTH WASHKITS WERE USED DURING THE SAME CASE. THE DEVICES WERE REPLACED WITH ANOTHER SET. THE CUSTOMER HAD TO DISCONTINUE THE CELL SAVER USAGE EVEN WHEN IT WAS REQUIRED FOR AUTOLOGOUS BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972894. One submission often covers many models, so check the product and lot details in each record.

• Z-1939-2010 · Apr 21, 2010 · Terminated
  Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the