Arthrex® ABS-10063Recalls & reported problems
Arthrex, Inc. · ANGEL cPRP PROCESSING SET USm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Angel cPRP processing set is used to separate platelets and plasma from a patient's own blood for preparing bone graft material during surgery. The 49 reports mostly describe leaking or splashing blood and fluid, holes in the tubing or cassette, and sets that would not fill, spin, or deliver the concentrated sample properly, so cases had to be repeated with another kit. There are 16 reports of patient injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00888867084001), received between May 17, 2018 and Dec 11, 2025 — classified as 16 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak15
- Leak/Splash10
- Defective Device8
- Break5
- Material Puncture/Hole4
- Output Problem4
- No Flow3
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information19
- No Known Impact Or Consequence To Patient4
- No Code Available3
- Exposure to Body Fluids2
- Erythema1
- Failure of Implant1
- Fever1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Material Puncture/Hole; Material Puncture/Hole
ON 11/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 ANGEL CPRP PROCESSING SET HAD A HOLE IN THE TUBING WHICH PREVENTED PROPER BLOOD FLOW. THE DEVICE BEGAN SQUEAKING AND DISPLAYED AN ERROR MESSAGE INDICATING AN INABILITY TO DRAW BLOOD INTO THE CHAMBER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777006 ↗MalfunctionDec 9, 2025Device Alarm System; Failure to Sense; Device Alarm System; Failure to Sense
ON 11/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 ANGEL CPRP PROCESSING SET CAUSED THE LIGHT SENSOR TO TRIGGER. 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 23760202 ↗MalfunctionMay 30, 2025Positioning Failure; Positioning Failure
ON 05/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 PRP KIT WAS NOT SCREWING INTO CENTRIFUGE PROPERLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115493 ↗MalfunctionFeb 10, 2025Output Problem; Output Problem
ON 01/16/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10063 PRP PROCESSING SET FAILED TO PROCESS. THIS OCCURRED DURING A CASE WHERE THEY PULLED BMA TO CONCENTRATE IN THE ANGEL CENTRIFUGE, THE FIRST TIME THE MACHINE TRIED TO DRAW THE BLOOD UP AND COULD NOT FILL THE ANGEL, THEY EMPTIED THE ANGEL AND TRIED TO REFILL THE ANGEL. THEN OPENED ANOTHER ANGEL KIT TO TRY AND PROCESS THE BLOOD TO GET THE CONCENTRATED BONE MARROW OUT, THE SAME ISSUE OCCURRED AND THE ANGEL SAID THERE WAS AIR DETECTED AND WOULD NOT COMPLETE THE SPIN.
Patient problems: Insufficient Information
MAUDE report 21345853 ↗MalfunctionFeb 10, 2025Output Problem; Output Problem
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED) (4) THAT AN ABS-10063 PRP PROCESSING SET FAILED TO PROCESS. THIS OCCURRED DURING A CASE WHERE THEY PULLED BMA TO CONCENTRATE IN THE ANGEL CENTRIFUGE, THE FIRST TIME THE MACHINE TRIED TO DRAW THE BLOOD UP AND COULD NOT FILL THE ANGEL, THEY EMPTIED THE ANGEL AND TRIED TO REFILL THE ANGEL. THEN OPENED ANOTHER ANGEL KIT TO TRY AND PROCESS THE BLOOD TO GET THE CONCENTRATED BONE MARROW OUT, THE SAME ISSUE OCCURRED AND THE ANGEL SAID THERE WAS AIR DETECTED AND WOULD NOT COMPLETE THE SPIN.
Patient problems: Insufficient Information
MAUDE report 21345852 ↗MalfunctionJan 20, 2025Output Problem; Output Problem
ON 12/23/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM, MALFUNCTIONED AND DID NOT OUTPUT THE PRP CORRECTLY WITH THIS KIT. THEY OPENED ANOTHER KIT TO FINISH THE PRP. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21190514 ↗MalfunctionDec 31, 2024No Flow; No Flow
ON 12/04/2024, A DISTRIBUTOR REPORTED VIA SEMS-(B)(4) THAT AN ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM, SEEMED TO HAVE AN ISSUE WITH THE TUBING THAT DID NOT ALLOW THE BLOOD TO FLOW FROM THE "WHOLE BLOOD IN" BAG. THEY WERE ABLE TO TRANSFER THE BLOOD TO ANOTHER KIT AND COMPLETE THEIR IN-OFFICE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/09/2024: THIS WAS IN A CLINICAL SETTING ON (B)(6) 2024 FOR A KNEE OA INJECTION PROCEDURE. THERE WAS NO VISIBLE LEAKING OR DAMAGE TO THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048759 ↗MalfunctionNov 11, 2024Leak/Splash; Leak/Splash
ON 10/29/2024 IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN ABS-10063 ANGEL PROCESSING SET HAD A LEAK FROM THE CASSETTE WHILE SPINNING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652918 ↗MalfunctionAug 12, 2024Defective Device; Defective Device
ON 07/18/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 2) OF AN ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM, WAS DEFECTIVE AND HAD ISSUES WITH THE ANTICOAGULANT. THEY WERE UNABLE TO USE IT DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961088 ↗MalfunctionAug 12, 2024Defective Device; Defective Device
ON 07/18/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (QTY. 2) OF AN ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM, WAS DEFECTIVE AND HAD ISSUES WITH THE ANTICOAGULANT. THEY WERE UNABLE TO USE IT DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960917 ↗MalfunctionMay 1, 2024Defective Device; Defective Device
ON 04/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN ABS-10063 CPRP PROCESSING SET WOULD NOT PROCESS. THIS OCCURRED DURING A CASE WHERE THEY INPUT 60CC OF WHOLE BLOOD IN AND THE MACHINE WOULD NOT PROCESS IT. AFTER ATTEMPTING TO RUN AND EMPTY THE SET MULTIPLE TIMES, THE DOCTOR TRANSFERRED THE BLOOD TO A NEW DISPOSABLE AND USED THE SAME MACHINE, AND IT WORKED JUST FINE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19222867 ↗MalfunctionApr 12, 2024Material Puncture/Hole; Material Puncture/Hole
ON 3/20/2024, A FACILITY REPRESENTATIVE VIA (B)(4) REPORTED THAT AN ABS-10063 CPRP PROCESSING SET TUBING WAS PUNCTURED WHEN USED, CREATING A HOLE DURING THE PROCEDURE AND CAUSING BLOOD TO POUR OUT. THE PATIENT'S BLOOD HAD TO BE RE-DRAWN DUE TO THE ISSUE TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: Insufficient Information
MAUDE report 19095562 ↗MalfunctionApr 8, 2024Output Problem; Output Problem
ON 03/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 CPRP PROCESSING SET EXPERIENCED NO PRODUCT OUTPUT. THIS OCCURRED DURING A PROCEDURE WHERE THE MACHINE SUCKED UP AND SPUN THE BLOOD THE FINAL OUTPUT SAID THERE WAS 8CC AND THE SYRINGE WAS EMPTY.
Patient problems: Insufficient Information
MAUDE report 19067343 ↗MalfunctionMar 28, 2024Failure to Eject; Failure to Eject
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN ABS-10063 PRP PROCESSING SET DID NOT EXPEL ANY RBCS, PPP, OR PRP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993615 ↗MalfunctionMar 15, 2024Fitting Problem; Fitting Problem
ON 02/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 PRP PROCESSING SET WOULD NOT CLICK INTO THE CENTRIFUGE. THE PLASTIC DISCS WERE TOO BIG. THIS OCCURRED DURING A CASE WHERE ONE FINALLY DID CLICK IN AND THEN THE MACHINE STARTED TO MAKE FUNNY NOISES AND SMELL LIKE SMOKE.
Patient problems: Insufficient Information
MAUDE report 18915182 ↗MalfunctionMar 13, 2024Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON 02/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 ANGEL PRP SET WHOLE BLOOD ADAPTOR IS ON THE OUTSIDE OF THE DEVICE INSTEAD OF THE INSIDE. WHEN THEY WENT TO PUT THE BLOOD IN, IT RAN OUT ALL OVER THE COUNTER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896967 ↗MalfunctionMar 11, 2024Material Puncture/Hole; Defective Device; Material Puncture/Hole; Defective Device
ADDITIONAL INFORMATION WAS RECEIVED ON 3/12/2024 VIA PHONE: THE ABS-10062 ARTHREX ANGEL BMC KIT HAD A HOLE IN THE TUBING. THIS WAS DISCOVERED DURING A BONE MARROW ASPIRATION PROCEDURE (B)(6) 2024. THERE WAS NO DELAY IN THE CASE REPORTED AND THE CASE WAS COMPLETED USING A ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM WITH NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18879636 ↗MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS PROVIDED ON 2/21/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THIS EVENT OCCURRED DURING A STAND-ALONE INJECTION ON 02/16/2024, THEY HAD TO MANUALLY PUMP BLOOD OUT OF THE MACHINE, DRAW INTO SYRINGE AND THEN PUT BLOOD IN A NEW KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874626 ↗MalfunctionFeb 6, 2024Crack; Crack
ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 CPRP PROCESSING SET TUBING WAS CRACKED AND THE BLOOD WAS NOT FLOWING SMOOTHLY. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18652820 ↗MalfunctionDec 22, 2023Defective Device; Defective Device
ADDITIONAL INFORMATION WAS PROVIDED ON 12/18/2023 WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED DURING A PERFUSION GROUP SPINNING FOR CARDIOTHORACIC PRP APPLICATION ON 11/09/2023. THE CASE WAS COMPLETED BY RE-SPINNING WITH A NEW CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18385829 ↗MalfunctionDec 20, 2023Use of Device Problem; Use of Device Problem
ON 11/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 PRP PROCESSING SET WOULD NOT ALLOW THE CENTRIFUGE TO DEPOSIT THE PRP INTO THE SYRINGE. THIS OCCURRED DURING USE, WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18362817 ↗MalfunctionNov 17, 2023Leak/Splash; Leak/Splash
ON 10/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 CPRP PROCESSING SET DIDN'T SIPHON OFF THE DIFFERENT CELLS AT THE END OF THE CYCLE, AND BLOOD SPILLED AFTER ATTEMPTING TO REMOVE THE DISC SET FROM AN ABS-10060R ANGEL CENTRIFUGE. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18163075 ↗MalfunctionNov 9, 2023Defective Device; Defective Device
ON 10/17/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN ABS-10063 PRP PROCESSING SET FAILED TO SEND PRP TO THE SYRINGE. THIS OCCURRED DURING A CASE WHERE NO PRP WAS SENT TO THE INJECTION SYRINGE. ANOTHER SPIN WAS DONE, BUT THE SAME RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18101873 ↗MalfunctionNov 3, 2023Device Emits Odor; Device Emits Odor
ON 10/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 CPRP PROCESSING SET, ARTHREX ANGEL SYSTEM HAS AN ISSUE WHEN THE CASSETTE WAS IN USE; IT GAVE AN ERROR CODE AND AN ODD BURNING SMELL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE (B)(6) 2023, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18067691 ↗MalfunctionJul 14, 2023No Device Output; No Device Output
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10063 PROCESSING SET DID NOT PRODUCE PPP,PRP, OR RBC. THIS OCCURRED DURING A CASE ON (B)(6) 2023, THE ANGEL PRP WAS RUN WITH WHOLE BLOOD AT NORMAL SOP 180ML AT 1% AND NO PRODUCT WAS PRODUCED PPP, PRP OR RBC OUTPUT. THE PATIENT WAS NOT ABLE TO RECEIVE THE PRODUCT ALTHOUGH THE MACHINE SHOWED COMPLETION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17329769 ↗
Other Platelet and plasma separator for bone graft handling devices
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- Arthrex® ABS-10060Arthrex, Inc. · Platelet and plasma separator for bone graft handling59 reports
- Arthrex® ABS-10011Arthrex, Inc. · Platelet and plasma separator for bone graft handling51 reports
- Arthrex® ABS-10062TArthrex, Inc. · Platelet and plasma separator for bone graft handling35 reports
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- Arthrex® ABS-2016-02Arthrex, Inc. · Platelet and plasma separator for bone graft handling7 reports
- ProGen PRP Advantage PROGEN-A15Bimini Technologies LLC · Platelet And Plasma Separator For Bone Graft Handling4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page