Arthrex® ABS-10061TRecalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00888867279919), received between Apr 5, 2018 and Dec 8, 2025 — classified as 11 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Use of Device Problem; Use of Device Problem

  ON 11/17/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060R ANGEL CENTRIFUGE MALFUNCTIONED AND WOULD NOT ADEQUATELY SEPARATE THE BLOOD AT THE END OF THE CYCLE DURING A PROCEDURE. THE ABS-10061T PRP KIT WAS UNABLE TO BE USED DUE TO THE IMPROPER FUNCTION OF THE CENTRIFUGE, BUT IT DID CONTAIN BLOOD FROM THE PATIENT WHO WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742411 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Puncture/Hole

  ON 11/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGLE PRP KIT DISPOSABLE SET WOULD NOT PULL BLOOD UP INTO THE CENTRIFUGE. THERE WAS A SMALL HOLE IN THE TUBING THAT IMPACTED THE PRESSURE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706320 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT TRIED TO MOVE THE BLOOD INTO THE CENTRIFUGE TO START THE SEPARATION PROCESS, BUT THERE WAS A HOLE IN THE TUBING, AND THE MACHINE WAS SUCKING AIR THROUGH IT AND WAS UNABLE TO PROCESS THE BLOOD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705588 ↗
• MalfunctionNov 26, 2025Failure to Calibrate; Failure to Calibrate

  ON 10/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T PRP KIT WAS CAUSING A LIGHT SENSOR TO NOT CALIBRATE. DURING A PRP SPIN, THE MACHINE REPEATEDLY INDICATED THAT THE LIGHT SENSOR COULD NOT BE CALIBRATED. A SECOND MACHINE WAS BROUGHT IN AND WAS GIVING THE SAME READING. WE OPENED A NEW PRP KIT AND TRANSFERRED THE PATIENT'S BLOOD INTO THAT MACHINE WAS ABLE TO PROCESS THAT SAMPLE. NOTICED DURING A CASE AND ABLE TO BE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657720 ↗
• MalfunctionNov 17, 2025Positioning Failure; Positioning Failure

  ON 10/30/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10061T ANGEL PRP KIT SEPARATION CHAMBER OR CASSETTE WASN'T SNAPPING INTO THE ADAPTOR CORRECTLY DURING AN ACL RECON PROCEDURE. THEY TRIED REMOVING AIR FROM THE BACKSIDE OF THE CASSETTE BY FLATTENING IT OUT AS WELL AS EXCESSIVELY ROTATING THE PUMP ROTOR IN A CLOCKWISE POSITION, BUT STILL COULDN'T GET THE SAFETY WINGS TO LOCK IN OR WORK CORRECTLY. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567735 ↗
• MalfunctionNov 4, 2025Device Emits Odor; Device Emits Odor

  ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT EXPERIENCED A MALFUNCTION. THE BLOOD WAS NOT PULLED UP DURING THE SPIN CYCLE AT ALL. THERE WAS ALSO A BURNING SMELL COMING FROM THE OUTLET WHERE THE MACHINE WAS PLUGGED IN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465206 ↗
• MalfunctionSep 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/12/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE KEPT GIVING AN INSUFFICIENT FILL ERROR - THERE WAS PLENTY OF BLOOD IN THE MACHINE. THIS OCCURRED DURING AN ANKLE FUSION WITH PRP FOR THE BONE GRAFT; THEY ENDED UP HAVING TO ABORT THE PROCEDURE, AND THE DISK WAS STUCK IN THE MACHINE AFTERWARD. THEY HAD SEVERAL PEOPLE TRY TO GET THE DISK OUT WITH NO LUCK. WE WERE ABLE TO FINISH THE CASE, BUT DID NOT END UP USING PRP TO MIX WITH BONE GRAFT; THE DOCTOR PULLED WHOLE BLOOD INSTEAD. ADDITIONAL INFORMATION WAS PROVIDED ON 08/19/2025 VIA PHONE, WHERE IT WAS CONFIRMED THAT THE PROCEDURE ITSELF WAS NOT ABORTED; HOWEVER, THE PRP PORTION OF IT WAS. THEY CONTINUED THE CASE BY REDRAWING BLOOD AND MIXING IT WITH THE BONE GRAFT. THE DISC THAT BECAME STUCK WAS AN ABS-10061T.

  Patient problems: Insufficient Information

  MAUDE report 22940442 ↗
• MalfunctionJul 15, 2025Defective Device; Defective Device

  ON 06/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) ABS-10061T ARTHREX ANGEL® PRP KITS MALFUNCTIONED. THIS OCCURRED DURING A ROTATOR CUFF CASE ON (B)(6) 2025, WHEN THE KITS WERE USED IN AN ATTEMPT TO COMPLETE THIS CASE, BOTH WERE UNSUCCESSFUL. THE FIRST KIT KEPT GETTING AN AIR DETECTED IN LINE ERROR, AND THEY TRANSFERRED THE BLOOD TO THE SECOND KIT, WHERE IT SPUN, BUT THE TRANSFER AT THE END WAS UNSUCCESSFUL. THE PPP WENT INTO THE PRP SYRINGE. THE CASE WAS COMPLETED, BUT THE USE OF PRP WAS OMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511539 ↗
• MalfunctionJul 15, 2025Defective Device; Defective Device

  ON 06/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) ABS-10061T ARTHREX ANGEL® PRP KITS MALFUNCTIONED. THIS OCCURRED DURING A ROTATOR CUFF CASE ON (B)(6) 2025, WHEN THE KITS WERE USED IN AN ATTEMPT TO COMPLETE THIS CASE, BOTH WERE UNSUCCESSFUL. THE FIRST KIT KEPT GETTING AN AIR DETECTED IN LINE ERROR, AND THEY TRANSFERRED THE BLOOD TO THE SECOND KIT, WHERE IT SPUN, BUT THE TRANSFER AT THE END WAS UNSUCCESSFUL. THE PPP WENT INTO THE PRP SYRINGE. THE CASE WAS COMPLETED, BUT THE USE OF PRP WAS OMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511534 ↗
• MalfunctionMay 28, 2025No Flow; No Flow

  ON 05/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGLE PRP KIT MALFUNCTIONED. WHEN ATTEMPTING TO INSERT WHOLE BLOOD INTO THE WHOLE BLOOD SECTION OF THE ITEM, THE BLOOD DID NOT GO THROUGH THE VALVE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095843 ↗
• MalfunctionApr 22, 2025No Flow; No Flow

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT MALFUNCTIONED AND WAS DAMAGED. THIS OCCURRED DURING A CASE WHILE ATTEMPTING TO SPIN BLOOD FOR PRP, THE ANGLE MACHINE MISJUDGED THE AMOUNT OF BLOOD THAT HAD BEEN TRANSFERRED TO THE CENTRIFUGE, WHICH RESULTED IN AN INSUFFICIENT AMOUNT OF BLOOD BEING SPUN, RESULTING IN A ZERO PRP YIELD. WE HAD TO DRAW ANOTHER 52 CC OF BLOOD FROM THE PATIENT, DELAYING THE CASE IN TOTAL ABOUT 30-40 MINUTES. THE TUBING ALSO WAS PUNCTURED DURING THE SPINNING, CAUSING A SMALL AMOUNT OF LEAKING OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884429 ↗
• MalfunctionFeb 3, 2025False Alarm; False Alarm

  ON (B)(6)2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS PRODUCING AN "AIR IN LINE ERROR". THIS OCCURRED DURING USE. ADDITIONAL INFORMATION WAS PROVIDED ON 01/10/2025 BY THE SALES REPRESENTATIVE VIA (B)(4) WHERE IT WAS STATED THAT THIS EVENT OCCURRED DURING A CARDIOTHORACIC PRP CASE ON 01/07/2025 THAT WAS NOT COMPLETED. AN ABS-10061T ARTHREX ANGEL® PRP KIT WAS BEING UTILIZED DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294656 ↗
• MalfunctionJan 20, 2025Output Problem; Output Problem

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT EXPERIENCED AN ISSUE WHERE THE PLASMA DID NOT COME OUT. THIS HAPPENED DURING A CASE, THERE WAS NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190636 ↗
• MalfunctionJan 13, 2025Material Puncture/Hole; Material Puncture/Hole

  ON 12/16/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT HAD A PUNCTURED HOSE. THE CASE WAS COMPLETED USING AN ADDITIONAL KIT. THERE WAS NO CASE DELAY. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THIS WAS DISCOVERED DURING A PRP FOR A SHOULDER PAIN PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137605 ↗
• MalfunctionJan 10, 2025Use of Device Problem; Use of Device Problem

  ON 12/13/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT HAD AN INCOMPLETE SEPARATION WITH THE BLOOD IN THE CARTRIDGE AND COULD NOT COMPLETE ITS FILLING. THEY USED AN ADDITIONAL KIT AND TRANSFERRED THE BLOOD TO COMPLETE THE CASE. THERE WAS A SLIGHT CASE DELAY. THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE ON 12/12/2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122968 ↗
• MalfunctionJan 10, 2025Device Alarm System; Device Alarm System

  ON 12/13/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA 4) THAT AN ABS-10061T ANGEL PRP KIT WAS LOADED INTO THE ANGEL MACHINE. THE MACHINE REPEATEDLY SUCKED UP A PORTION OF THE BLOOD, BUT THEN WOULD REPORT AN ERROR OF RUNNING OUT OF BLOOD. THIS CONTINUED AND KEPT REPORTING THAT THERE WAS A LIGHT ERROR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122889 ↗
• MalfunctionDec 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06722915 THAT AN ABS-10061T ANGEL DISC PLASTIC IS TOO THICK AND UNABLE TO LOAD IN ANGEL MACHINE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. IT DID NOT HARM THE PATIENT AS THEY HAD ANOTHER ANGEL KIT AND WERE ABLE TO PUT THE BLOOD IN THE ONE THAT WORKED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020183 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ANGEL PRP KIT MALFUNCTIONED AND BLOOD LEAKED OUT OF THE DEVICE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546207 ↗
• MalfunctionOct 16, 2024Improper Flow or Infusion; Improper Flow or Infusion

  ON 10/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO ABS-10061T ARTHREX ANGEL PRP KITS ARE EXPERIENCING AN ISSUE. CONTACT HAS STATED THAT THE MACHINES ARE SHOWING ERROR CODES. THEY ARE SAYING THAT THE CHAMBERS ARE BEING SPIT OUT. 3 MINUTES LEFT AFTER EVERY SPIN, THE MACHINE WILL PAUSE, AND THEY WOULD HAVE TO HIT PLAY. THEY ARE ONLY GETTING 1 CC INSTEAD OF 3 CC'S. TAC HAS SENT SOME TROUBLESHOOTING STEPS AND IS AWAITING A RESPONSE FROM THE CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 20463967 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON 10/03/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT LEAKED. THE ISSUE OCCURRED AFTER THE CASE WAS COMPLETED. WHEN REMOVING THE DISPOSABLE SET FROM THE MACHINE, THE TECHNICIAN DISCOVERED BLOOD LEAKING FROM PART OF THE TUBE THAT SITS INSIDE THE ¿BLUE SENSOR¿ AREA OF THE MACHINE. NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462147 ↗
• MalfunctionOct 14, 2024Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ON 10/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO ABS-10061T ARTHREX ANGEL PRP KITS ARE EXPERIENCING AN ISSUE. CONTACT HAS STATED THAT THE MACHINES ARE SHOWING ERROR CODES. THEY ARE SAYING THAT THE CHAMBERS ARE BEING SPIT OUT. 3 MINUTES LEFT AFTER EVERY SPIN, THE MACHINE WILL PAUSE, AND THEY WOULD HAVE TO HIT PLAY. THEY ARE ONLY GETTING 1 CC INSTEAD OF 3 CC'S. TAC HAS SENT SOME TROUBLESHOOTING STEPS AND IS AWAITING A RESPONSE FROM THE CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 20438862 ↗
• MalfunctionOct 11, 2024Defective Device; Defective Device

  ON 10/03/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06678785 THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT WAS DAMAGED AND FAULTY WHEN IN USE. THIS OCCURRED DURING USE, THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 20428966 ↗
• MalfunctionJul 19, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  ON 07/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT ACTUAL BAG FOR THE BLOOD WOULDN'T CONNECT WITHIN THE CENTRIFUGE, AND WOULD NOT PULL ANY BLOOD UP.

  Patient problems: Insufficient Information

  MAUDE report 19783771 ↗
• InjuryJun 27, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  ADDITIONAL INFORMATION WAS PROVIDED ON 06/11/2024 WHERE THE FACILITY REPRESENTATIVE STATED THAT THE DATE OF THE BLOODBORNE NEEDLE STICK WAS ON (B)(6) 2024. THE INCIDENT TOOK PLACE DURING A PRP BLOOD DRAW USING THE ARTHREX ANGEL PRP KIT. AS PART OF THE KIT, WAS A WINGED INFUSION KIT THAT HAS A COVER THAT FLIPS OVER THE NEEDLE TO PROTECT THE WORKER. IN THIS INSTANCE, THE GUARD DID NOT CLICK INTO PLACE AND EXPOSED THE NEEDLE WHEN THE WORKER WAS CLEANING UP THE AREA.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19623111 ↗
• MalfunctionJun 21, 2024Activation Failure; Activation Failure

  ON 05/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT WHEN THE CARTRIDGE OF AN ABS-10061T ARTHREX ANGEL PRP KIT WAS SEATED, A LASER SLIGHT WOULD START BLINKING. WHEN THE CARTRIDGE WAS TAKEN OFF, THE LASER LIGHT STOPPED BLINKING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A DIFFERENT KIT. TS DONE: CLEANED OFF THE LASER LIGHT WITH A DUST FREE CLOTH MULTIPLE TIMES AND TURNED OFF THE MACHINE AND RESEATED THE CARTRIDGE. THIS DID NOT SOLVE THE ISSUE, WHEN THE CARTRIDGE WAS SEATED IT WOULD START BLINKING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583948 ↗