Arthrex® ABS-10062TRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888867239951), received between Mar 7, 2018 and Jan 6, 2026 — classified as 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026No Flow

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS MAKING A GRINDING NOISE AND STOPPED PULLING FROM THE "BLOOD IN" BAG OF AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. THE CASE WAS COMPLETED WITH ANOTHER ANGEL AND A REPLACEMENT KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974769 ↗
• MalfunctionDec 5, 2025Positioning Failure; Positioning Failure

  ON 11/12/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE ABS-10062T JAMSHIDI TROCAR DID NOT PROPERLY LOCK INTO ITS CORRESPONDING COMPONENT AT THE PROXIMAL END NEAR THE GREEN LOCKING MECHANISM. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727106 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem

  ON 10/28/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 2) ABS-10062T ANGEL SYSTEMS WITH ASPIRATION KIT WITH ACD-A WOULD NOT ALLOW THE ANGEL TO RUN DURING A CASE. THEY WERE BOTH COLLECTING THE BONE MARROW INTO THE CARTRIDGE BUT WOULDN'T COUNT THE AMOUNT BEING PULLED. THIS WOULDN'T ALLOW THEM TO RUN THE CYCLE BECAUSE IT WAS THOUGHT THERE WAS NOT ENOUGH FLUID. NO PATIENTS WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534866 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem

  ON 10/28/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 2) ABS-10062T ANGEL SYSTEMS WITH ASPIRATION KIT WITH ACD-A WOULD NOT ALLOW THE ANGEL TO RUN DURING A CASE. THEY WERE BOTH COLLECTING THE BONE MARROW INTO THE CARTRIDGE BUT WOULDN'T COUNT THE AMOUNT BEING PULLED. THIS WOULDN'T ALLOW THEM TO RUN THE CYCLE BECAUSE IT THOUGHT THERE WAS NOT ENOUGH FLUID. NO PATIENTS WERE HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534818 ↗
• MalfunctionMay 29, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 05/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL SYSTEM WITH ASPIRATION KIT CARTRIDGE WOULD NOT CLICK INTO MACHINE. THIS WAS DISCOVERED DURING THE CASE AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109835 ↗
• MalfunctionMay 28, 2025Failure to Advance; Failure to Advance

  ON 05/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL SYSTEM WITH ASPIRATION KIT SEPARATION CHAMBER IN THE PROCESSING KIT DID NOT LOCK INTO THE CENTRIFUGE. 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 22095747 ↗
• MalfunctionMay 20, 2025Use of Device Problem; Use of Device Problem

  ON 05/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL SYSTEM WITH ASPIRATION KIT VALVE POSITION ERROR PREVENTED BMAC FROM BEING PRODUCED. PPP WAS USED FOR THE PATIENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055447 ↗
• MalfunctionMay 19, 2025Air/Gas in Device; Air/Gas in Device

  ON 04/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT (COMPONENT OF ABS-2016-02, LOT: CRT240719-830) WHEN OPENED FROM THE PACKAGE AND LOADED IN THE ANGEL; THERE WAS AIR IN THE CENTRAL CARTRIDGE, AND THE ANGEL COULD NOT COMPLETE THE TASK. THEY USED ANOTHER KIT TO COMPLETE THE CASE. NO PATIENT WAS AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 04/30/2025: THIS WAS A PROCEDURE WITH ANESTHESIA FOR A ROTATOR CUFF REPAIR. NO PHOTOS WERE TAKEN OF THE ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044574 ↗
• MalfunctionMar 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ON 02/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10062T ANGEL® CPRP SYSTEM WITH ASPIRATION KIT HAD NO FLUID COMING OUT. THIS OCCURRED DURING A CASE THAT WENT FULL CYCLE, A SEVENTEEN-MINUTE SPIN, AND SHOWED CC; HOWEVER, FLUID DID NOT COME OUT. ADDITIONAL INFORMATION WAS PROVIDED ON 02/26/2025 WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED ON (B)(6) 2025 DURING AN ACHILLES CASE. THE PATIENT WENT WITHOUT PRP FOR THIS CASE.

  Patient problems: Insufficient Information

  MAUDE report 21524605 ↗
• MalfunctionNov 20, 2024No Flow; No Flow

  ON 10/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL® CPRP SYSTEM WITH ASPIRATION KIT MALFUNCTIONED. THIS OCCURRED DURING USE WHEN THEY RAN BONE MARROW IN THE ANGEL MACHINE, AND THE KIT DID NOT GIVE ANY PRP. THEY PUT IN ABOUT 55CC OF MARROW AND RAN THE MACHINE ON 50CC TOTAL VOLUME. IT TURNED OUT ONLY 42CC GOT PROCESSED, THE MACHINE WHISTLED LOUDLY AND SAID INSUFFICIENT FILL, SO THEY REPROCESSED THE SAME BLOOD ON 40 TOTAL VOLUME, AND IT WHISTLED REALLY LOUDLY AGAIN. THEN WHEN IT DISTRIBUTED THE PRODUCT TO EACH BAG, NOTHING WENT INTO THE PRP SYRINGE, EVEN THOUGH THEY PRIMED IT.

  Patient problems: Insufficient Information

  MAUDE report 20735196 ↗
• MalfunctionOct 2, 2024Material Puncture/Hole; Material Puncture/Hole

  ON 09/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN ABS-10062T ANGEL® CPRP SYSTEM WITH ASPIRATION KIT HAD A HOLE IN THE TUBING AND WASN'T ABLE TO PROCESS THE BLOOD. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354459 ↗
• MalfunctionSep 9, 2024Expiration Date Error; Expiration Date Error

  ON 8/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT WAS USED ON A PATIENT PAST ITS EXPIRATION DATE. THIS WAS DISCOVERED POST-OPERATIVE OF A COTTON OSTEOTOMY AND FUSION PROCEDURE ON (B)(6) 2024. THE PRODUCT EXPIRED ON 7/31/2024.

  Patient problems: Insufficient Information

  MAUDE report 20168491 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10062T ARTHREX ANGEL CPRP & BMA TRAY HAD A CRACK IN THE FILTER OF THE ANGEL BMA KIT AROUND THE NECK AREA, CAUSING THE FILTER TO FULLY BREAK AS THE SYRINGE WAS INJECTING BMA. NOTHING BROKE OFF INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER INFORMATION. THIS WAS DISCOVERED DURING A SCOPE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162579 ↗
• MalfunctionJun 26, 2024Defective Device; Defective Device

  ON 05/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN ANGEL MACHINE WOULDN'T CALIBRATE THE AMOUNT OF BLOOD GOING INTO THE CENTRIFUGE AND WOULD NOT SPIN BUT MOST OF THE BLOOD WAS IN THE ABS-10062T ANGEL® CPRP SYSTEM WITH ASPIRATION KITS DISC AND COULDN'T BE SAVED. THE CASE WAS COMPLETED USING ANOTHER ANGEL MACHINE AND A NEW DISC. ADDITIONAL INFORMATION WAS PROVIDED ON 06/05/2024 VIA (B)(4) WHERE THE SALES REPRESENTATIVE REPORTED THAT AN ABS-10060 ANGEL MACHINE HAS CONTINUED TO GIVE THEM TROUBLE AND MALFUNCTION WITH MULTIPLE ERRORS. THE MOST RECENT ERROR IS AIR BEING DETECTED IN THE TUBING. IN SOME INSTANCES, THEY HAVE BEEN ABLE TO TAKE THE SAME KIT AND MOVE TO AN ALTERNATIVE CENTRIFUGE, AND THE AIR WAS NO LONGER DETECTED LEAVING THEM TO BELIEVE THE ISSUE IS ISOLATED TO THIS MACHINE ANGEL MACHINE STRICTLY THAT IS ACTING UP.

  Patient problems: Insufficient Information

  MAUDE report 19620524 ↗
• MalfunctionMar 20, 2024Backflow; Backflow

  ON 2/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT HAD THE BAG CYCLING THE BLOOD UP THE CENTRIFUGE. THE CASE WAS COMPLETED BY TAKING OUT THE BLOOD AND REPLACING IT WITH ANOTHER ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT FROM THE SAME LOT, AND THEN THE CENTRIFUGE COULD SPIN THE BLOOD WITH NO ISSUES. THERE WAS A FEW-MINUTE DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN OCL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942393 ↗
• MalfunctionDec 12, 2023Defective Device; Defective Device

  ON 11/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T PRP SYSTEM WITH ASPIRATION KIT WAS FILLING UP THE PRP SYRINGE WITH AIR UP TO 17CC¿S WHILE NO BLOOD WAS LEAVING THE DISC. THIS OCCURRED DURING USE, WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314331 ↗
• MalfunctionNov 10, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ASPIRATION KIT DID NOT FUNCTION PROPERLY. THIS OCCURRED DURING A CASE AND THEY FOLLOWED ALL THE STEPS IN SETTING UP THE MACHINE, FILTERED THE BONE MARROW, AND HIT THE GREEN START BUTTON TO PROCESS THE BMA. THE BMA WOULD DRAW UP AND GET AROUND THE BLACK ROTOR BUT THEN WOULD NOT GET INTO THE CASSETTE. THEY EMPTIED THE CASSETTE AND TRIED A SECOND TIME. THEY THEN OPENED A SECOND ABS-10062T WITHDREW THE BMA FROM THE FIRST KIT AND PROCESSED IT IN THE NEW ONE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110824 ↗
• MalfunctionNov 9, 2023Defective Device; Defective Device

  ON 10/19/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN ABS-10060 ANGEL MACHINE WAS NOT PULLING BLOOD INTO THE ABS-10062T KITS DISC. A NEW KIT WAS USED TO CONTINUE WITH THE CASE. THEY HAD TO REDRAW THE BLOOD, WHICH CAUSED A SLIGHT DELAY HOWEVER THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103801 ↗
• MalfunctionNov 9, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN ABS-10062T PRP SYSTEM WITH ASPIRATION KIT WOULDN'T PULL THE BONE MARROW INTO THE SEPARATION CHAMBER, BUT THE ANGEL WAS COUNTING LIKE IT WAS. THIS OCCURRED DURING A CASE WHERE YOU COULD HEAR A SLIGHT SEEPING AT THE ROTOR WHEEL. THEY TRIED THE SAME TUBE IN A DIFFERENT ANGLE CENTRIFUGE, AND IT STILL WOULD NOT PULL THE BONE MARROW. THEY THEN TRANSFERRED THE BONE MARROW INTO A SEPARATE KIT, AND EVERYTHING WORKED FINE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103660 ↗
• MalfunctionNov 1, 2023Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10062T ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA HAD A HOLE IN THE TUBING AND WOULD NOT FILL THE CENTRIFUGE WITH BLOOD. IT WAS STATED THAT NO BLOOD LEAKED OUT OF THE TUBING AND NO EXPOSURE OF BODILY FLUIDS TO STAFF OR THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER KIT. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A REVISION ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048627 ↗
• MalfunctionFeb 6, 2023Disconnection; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10062T ASPIRATION KITS CASSETTE HUB UN-ATTACHED FROM THE BAG AT THE CENTRAL PORT. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302903 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Material Puncture/Hole

  ON 11/04/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10062T ASPIRATION KIT, AND A ABS-10061T PRP KITS TUBING FROM THE KITS HAD HOLES IN THEM AND BLOOD WAS LEAKING OUT. THIS OCCURRED DURING A PRP/BMC CASE ON (B)(6) 2022. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842812 ↗
• MalfunctionAug 1, 2022Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10062T ANGELS SYSTEM TUBING BECAME DISCONNECTED, CAUSING BLOOD TO SPRAY ALL OVER. THIS WAS DISCOVERED DURING A CASE WITH EXPOSURE TO BODILY FLUIDS.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15137823 ↗
• MalfunctionDec 7, 2021Material Puncture/Hole

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2), ABS-10062T KIT BONE MARROW ASPIRATION KITS, (LINE #1) LOT NUMBER: 122411758 AND (LINE # 2)LOT NUMBER: 1172113356 HAD HOLES IN THE TUBING THAT GO AROUND THE ROTOR. THIS WAS DISCOVERED DURING USE IN A BONE MORROW ASPIRATION PROCEDURE ON (B)(6) 2021. DURING THE SPIN THERE WAS BLOOD GOING ALL OVER THE PLACE. THE PROCESS WAS COMPLETED BY OPENING A NEW BMC KIT.

  Patient problems: Insufficient Information

  MAUDE report 12954126 ↗
• MalfunctionDec 7, 2021Material Puncture/Hole

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2), ABS-10062T KIT BONE MARROW ASPIRATION KITS, (LINE #1) LOT NUMBER: 122411758 AND (LINE # 2) LOT NUMBER: 1172113356 HAD HOLES IN THE TUBING THAT GO AROUND THE ROTOR. THIS WAS DISCOVERED DURING USE IN A BONE MORROW ASPIRATION PROCEDURE ON (B)(6) 2021. DURING THE SPIN THERE WAS BLOOD GOING ALL OVER THE PLACE. THE PROCESS WAS COMPLETED BY OPENING A NEW BMC KIT.

  Patient problems: Insufficient Information

  MAUDE report 12954084 ↗