Arthrex® ABS-10060Recalls & reported problems
Arthrex, Inc. · ANGEL PRP SYSTEM CENTRIFUGE US (NEW) · Class 2
Quick summary
This Arthrex ANGEL PRP centrifuge spins blood to separate platelet-rich plasma for bone grafting. The 62 reports mostly describe the unit making loud grinding or burning noises, sparking, failing to read the blood volume correctly, and disposable processing kits leaking or coming apart mid-spin — in one case spraying blood onto two users who went to the emergency room for bloodborne exposure. Seven injuries and no deaths are reported. 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
- 59
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00888867083974), received between Feb 11, 2020 and Jan 12, 2026 — classified as 7 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Defective Device” (17 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.
Reports received per month
Most reported problems
Device problems
- Defective Device17
- Use of Device Problem9
- Device Emits Odor5
- Fluid/Blood Leak5
- Output Problem4
- Leak/Splash3
- Break2
- False Alarm2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information20
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Exposure to Body Fluids1
- Syncope/Fainting1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026False Alarm
ADDITIONAL INFORMATION WAS PROVIDED ON 29-DEC-2025 WHERE THE SALES REPRESENTATIVE STATED THAT REPORTED VIA (B)(4) THAT AN ABS-10061T WAS USED WITH THE CENTRIFUGE. THE CASE WAS DELAYED 30-MINUTES AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 24039707 ↗MalfunctionJan 6, 2026Defective Device; Noise, Audible
ON 17-DEC-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 23973601 ↗MalfunctionJan 5, 2026Use of Device Problem
ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS HAVING ISSUES AND NOT WORKING CORRECTLY. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED BY EMPTYING THE CARTRIDGE AND REDOING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957249 ↗MalfunctionJan 5, 2026Use of Device Problem; Connection Problem
ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS HAVING ISSUES AND NOT WORKING CORRECTLY. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED BY EMPTYING THE CARTRIDGE AND REDOING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956844 ↗MalfunctionNov 13, 2025Volume Accuracy Problem; Volume Accuracy Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE DID NOT REGISTER THE VOLUME OF BLOOD PROPERLY. IT MISREAD THE VOLUME AS 15CC WHEN REALLY IT WAS 50CC. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542057 ↗MalfunctionNov 12, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 CENTRIFUGE IS NOT WORKING PROPERLY. NOTICED DURING A CASE AND SWAPPED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534449 ↗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-10060 ANGEL PRP SYSTEM CENTRIFUGE BLOOD WAS NOT PULLED UP DURING THE SPIN CYCLE AT ALL AND THEN THERE WAS 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 23465087 ↗MalfunctionNov 4, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
ON 10/23/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL PRP CENTRIFUGE TOUCHSCREEN WAS NOT RESPONDING DURING A CASE. THE TEAM HAD TO SWITCH TO A NEW UNIT MID-PROCEDURE. THERE WERE NO ADVERSE PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463609 ↗MalfunctionSep 2, 2025Use of Device Problem; Use of Device Problem
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 22940130 ↗MalfunctionJul 30, 2025Computer Software Problem; Computer Software Problem
ON 07/8/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 PRP SYSTEM IS CONSISTENTLY GETTING A SOFTWARE ERROR MESSAGE. DISCOVERED DURING A BCM/HARVEST SPIN PROCEDURE, DEVICE SWAPPED, AND CASE WAS COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22665357 ↗MalfunctionJul 14, 2025Device Emits Odor; Device Emits Odor
ON 06/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS SPINNING DOWN, AND A STRONG BURNING SMELL CAME FROM THE MACHINE. THEY DIDN'T STOP/PAUSE THE SPIN BECAUSE THEY WERE RIGHT IN THE MIDDLE OF IT, THEY NEVER SAW ANY SMOKE, JUST THE FOUL ODOR. THEY INSTALLED THE DISC PROPERLY, ALL TUBING UNKINKED. IT STILL SPIT OUT PRP WHEN THE SPIN WAS DONE, SO THEY BELIEVE THE MACHINE IS STILL WORKING.
Patient problems: Insufficient Information
MAUDE report 22501290 ↗MalfunctionJun 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 05/27/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL PRP CENTRIFUGE WOULD NOT SPIN PROPERLY OR WOULDN'T SPIN AT ALL. A CASE WAS INVOLVED, WITH NO ADVERSE EFFECTS FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284871 ↗MalfunctionJun 3, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL PRP SYSTEM CENTRIFUGE DISPLAYED DIFFERENT ERROR CODES. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134315 ↗MalfunctionMay 5, 2025Break; Break
ON 04/16/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE BLACK HANDLE BROKE. THIS OCCURRED DURING A CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21960284 ↗MalfunctionFeb 13, 2025Use of Device Problem; Use of Device Problem
ON 01/27/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS OCCASIONALLY GIVING AN ERROR MESSAGE FOR THE LIGHT SENSOR. WHEN POWERED ON AND OFF, THEY CAN TYPICALLY GET IT TO GO AWAY. THIS OCCURRED DURING USE WITH NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376521 ↗MalfunctionFeb 12, 2025Pressure Problem; Pumping Problem; Pressure Problem; Pumping Problem
ON 01/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS NOT PUMPING BACK. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21366311 ↗MalfunctionFeb 10, 2025Use of Device Problem; Use of Device Problem
ON 01/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS SHOWING A LIGHT SENSOR ALARM. THE FACILITY WAS UNABLE TO TROUBLESHOOT AND BYPASS THE SENSOR BY COVERING IT AND MOVING THE MACHINE TO A DARK ROOM. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. A NEW ANGEL MACHINE WAS BROUGHT IN TO COMPLETE THE BMAC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21344875 ↗MalfunctionFeb 3, 2025Device Alarm System; False Alarm; Device Alarm System; False Alarm
ON 01/07/2025, 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 (B)(6)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 21294659 ↗MalfunctionJan 15, 2025Use of Device Problem; Use of Device Problem
ON 12/19/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06739359 THAT AN ABS-10060 ANGEL PRP SYSTEM CENTRIFUGE US (NEW) WAS DISPLAYING MANY ERROR CODES WHEN IN USE AND CONTINUED TO PAUSE DURING MID-SPIN. THEY TRIED WIPING DOWN THE LASER AND EYEPIECE, BUT THE ISSUE PERSISTED. THEY HAD TO KEEP PRESSING TO MAKE THE DEVICE WORK. 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 21157704 ↗MalfunctionJan 10, 2025Use of Device Problem; Use of Device Problem
ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL PRP SYSTEM CENTRIFUGE US (NEW) PUMP MOTOR KEEPS POPPING OUT WHEN THE ANGEL IS FILLING AND UN-FILLING. THE PERFUSIONIST HAD TO PUT HIS FINGER ON IT SO IT WOULD NOT KEEP POPPING UP. 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 21122828 ↗MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak
ON 10/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06684670 THAT AN ABS-10060 ANGEL CENTRIFUGE 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 20557074 ↗MalfunctionOct 16, 2024Separation Failure; Separation Failure
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS UNABLE TO SPIN AND SEPARATE. THIS OCCURRED DURING A CASE, WHERE THE CENTRIFUGE WAS UNABLE TO SPIN AND SEPARATE. THEY REPORTED BUBBLES GETTING MIXED IN WITH THE BLOOD. THERE WERE NO ERROR ALERTS PRESENT. THE SURGEON DID HAVE TO DRAW BLOOD AND RE-SPIN AGAIN WITH NO SUCCESS. THE CASE WAS ONLY DELAYED.
Patient problems: Insufficient Information
MAUDE report 20463168 ↗MalfunctionOct 8, 2024Defective Device; Defective Device
ON 10/03/2024, ADDITIONAL INFORMATION WAS PROVIDED BY A SALES REPRESENTATIVE WHO STATE THAT "ON (B)(6) 2024 WE HAD AN AVASCULAR NECROSIS DECOMPRESSION CASE OF THE HIP WITH DR. (B)(6) IN THE OPERATING ROOM. WE USED THE CLINIC'S ANGEL MACHINE WITH BMA. THE MACHINE WAS CONNECTED PROPERLY, OTHER THAN NOT BEING ABLE TO CLICK IN THE SEPARATION CHAMBER. WE INJECTED AN INPUT OF 80 ML. WHEN PRESSING RUN, THE CHAMBER GOT STUCK AS IT BEGAN TO SPIN. BY THIS TIME, THE DOCTOR HAD ALREADY DECOMPRESSED HIS LESION, MADE A TUNNEL, AND WAS READY FOR PRP. THE SOLUTION WAS TO HAVE 3 STAFF MEMBERS, INCLUDING THE SURGEON, HOLDING THE SILVER OUTSIDE OF THE CHAMBER WHILE, I WITH A LOT OF FORCE PUSHING AND TURNING CLOCKWISE TO CLICK THE SEPARATION CHAMBER IN. WE WERE ABLE TO RUN IT AS USUAL WITH 5ML OF OUTPUT. THIS ISSUE LED TO A 15-MINUTE DELAY OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397142 ↗MalfunctionSep 23, 2024Output Problem; Output Problem
ON 09/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN ABS-10060 ANGEL CENTRIFUGE WAS NOT OUT PUTTING THE PROPER AMOUNTS OF PRP. THE ISSUE OCCURRED WITH A FEW DIFFERENT KITS WITH THE SAME OUTCOME OF 20CC+ OF PRP.
Patient problems: Insufficient Information
MAUDE report 20277916 ↗MalfunctionAug 15, 2024Separation Failure; Separation Failure
ON 07/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL MACHINE. FAILED TO ¿SEPARATE¿ AUTOLOGOUS FLUID INTO ITS DESIGNATED SPOTS. THE ANGEL MACHINE DUMPS ALL FLUID BACK INTO THE ¿WHOLE BLOOD IN¿ SECTION OF THE ANGEL CASSETTE BAGS. THIS OCCURRED DURING A CASE WHERE THE PATIENT DID NOT RECEIVE THE BMA AS IT DID NOT GET SEPARATED IN ANGEL.
Patient problems: Insufficient Information
MAUDE report 19992852 ↗
Other Platelet and plasma separator for bone graft handling devices
- Arthrex® ABS-10061TArthrex, Inc. · Platelet and plasma separator for bone graft handling75 reports
- Arthrex® ABS-10060RArthrex, Inc. · Platelet and plasma separator for bone graft handling66 reports
- Arthrex® ABS-10011Arthrex, Inc. · Platelet and plasma separator for bone graft handling51 reports
- Arthrex® ABS-10063Arthrex, Inc. · Platelet and plasma separator for bone graft handling49 reports
- Arthrex® ABS-10062TArthrex, Inc. · Platelet and plasma separator for bone graft handling35 reports
- Arthrex® ABS-10080Arthrex, Inc. · Platelet and plasma separator for bone graft handling9 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.