Arthrex® ABS-10010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00888867083790), received between Apr 27, 2018 and Dec 21, 2023 — classified as 15 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Defective Device; Defective Device

  ON 11/21/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) ABS-10010S DOUBLE SYRINGE SYSTEMS FAILED. THIS OCCURRED DURING A CASE WHERE THE FIRST SYRINGE LACKED SUCTION, AND THE PLUNGER WOULD NOT PULL BACK INSIDE THE SYRINGE. THE SECOND SYRINGE'S BLACK PORTION WAS NOT CONNECTED INSIDE THE SYRINGE, CAUSING BLOOD TO LEAK OUT EVERYWHERE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 18375683 ↗
• InjuryJul 3, 2023Leak/Splash; Leak/Splash

  ON 6/6/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN ABS-10010S ACP DOUBLE SYRINGE SYSTEM HAD AN ISSUE. DURING A BILATERAL KNEE PRP PROCEDURE WITH ACP DOUBLE SYRINGES ON (B)(6) 2023, THERE WAS A MALFUNCTIONING ERROR WITH THE TWO-WAY SHUT-OFF VALVE. THERE WAS NO WAY TO SHUT OFF THE TWO-WAY FLOW. BLOOD WAS GOING EVERYWHERE DESPITE TURNING IT EITHER WAY. THEY WERE FORCED TO DISPOSE OF THE KIT AND OPEN A NEW ONE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. ON 6/13/2023, THE DISTRIBUTOR PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THEY WERE EXPOSED TO THE BLOOD AS IT WAS SPILLING OUT OF THE TUBING. THE SITE WAS DECONTAMINATED PER THE STANDARD DECONTAMINATION PROCEDURE. NO ANTI-COAGULANT WAS USED, AND NO AIR BUBBLES WERE OBSERVED DURING THE BLOOD DRAW. NO IMPACT OR HARM TO THE PATIENT OR THE FACILITY STAFF WAS REPORTED, AS PPE WAS USED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 17246141 ↗
• MalfunctionJun 9, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS. THAT AN ABS-10010S DOUBLE SYRINGE SYSTEM, WHEN THEY WERE DRAWING BLOOD. THE SYRINGE LOST SUCTION AND THE BOTTOM SYRINGE DETACHED FROM THE REST OF THE KIT, CAUSING THE BLOOD TO COME OUT OF THE SYRINGE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 17098631 ↗
• MalfunctionJun 7, 2023Leak/Splash; Leak/Splash

  ON 05/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) ABS-10010S DOUBLE SYRINGE SYSTEMS LEAKED. THIS OCCURRED DURING A CASE, WITH NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 05/17/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A PRP INJECTION ON 05/10/2023. THE SPILL WAS NOT CONTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079012 ↗
• MalfunctionJun 7, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) ABS-10010S DOUBLE SYRINGE SYSTEMS LEAKED. THIS OCCURRED DURING A CASE, WITH NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 05/17/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A PRP INJECTION ON (B)(6) 2023. THE SPILL WAS NOT CONTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079004 ↗
• MalfunctionJan 16, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Pressure Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10010S ARTHREX ACP DOUBLE SYRINGE SYSTEM HAD AN ISSUE. WHEN THE BLOOD WAS BEING DRAWN THE PRESSURE CAUSED THE CAP TO COME OFF AND THE BLOOD SPILLED EVERYWHERE. THE CASE WAS COMPLETED BY USING A NEW DEVICE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16173337 ↗
• MalfunctionNov 14, 2022Disconnection; Fluid/Blood Leak; Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A ABS-10010S DOUBLE SYRINGE SYSTEMS INNER SYRINGE FELL OFF THE OUTER SYRINGE AND CONTENT SPILLED ALL OVER THE FLOOR. THIS OCCURRED DURING AN UNKNOWN PROCEDURE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788085 ↗
• MalfunctionNov 9, 2022Break

  ON 10/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) ABS-10010S DOUBLE SYRINGE SYSTEM. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE, WHEN THE SYRINGES CAME APART AND BLOOD SPILLED EVERYWHERE. THE PRP DID NOT SEPARATE PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758630 ↗
• MalfunctionOct 24, 2022Suction Problem

  ON 10/7/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10010S ARTHREX ACP DOUBLE SYRINGE SYSTEM HAD AN ISSUE. WHEN PULLING THE UNIT IT DIDN'T SEPARATE THE PLASMA AND BLOOD SPILLED. THE BLACK CAP DID NOT SUCK OUT THE BLOOD AS INTENDED. NO PATIENT HARM OR ADVERSE EVENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657680 ↗
• MalfunctionSep 26, 2022Fluid/Blood Leak

  ON (B)(6) /2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10010S ARTHREX ACP® DOUBLE SYRINGE SYSTEM HAD AN ISSUE. THE SYRINGE/PLUNGER PULLED OUT CAUSING BLOOD TO LEAK FROM THE SYRINGE. ANOTHER SYRINGE WAS USED SUCCESSFULLY AND THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS DISCARDED AS IT HAD BLOOD ON IT. THIS WAS DISCOVERED DURING USE ON (B)(6) 2022 WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION OVER THE PHONE: THIS EVENT OCCURRED DURING A PRP PROCEDURE. NEITHER THE PATIENT NOR THE FACILITY STAFF WAS HARMED, AND EVEN THOUGH IT WAS NOT SPECIFIED HOW THE AREA WAS DECONTAMINATED, THEY WERE FOLLOWING A STANDARD DECONTAMINATION PROCEDURE, AND ANOTHER SYRINGE THEN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ANTI-COAGULANT WAS USED, AND IT WAS NOT SPECIFIED IF AIR BUBBLES WERE OBSERVED DURING THE BLOOD DRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484391 ↗
• MalfunctionJun 13, 2022Output Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10010S ACP DOUBLE SYRINGE SYSTEM HAD AN ISSUE DURING A BLOOD DRAW ON (B)(6) 2022 ON THE LEFT ARM FOR AN ACP INJECTION. WHEN THE DOCTOR WAS PULLING BACK ON THE SYRINGE TO DRAW BLOOD FROM THE LEFT ARM, THE SYRINGE DID NOT HAVE THE HARD STOP IN THE OUTER SYRINGE IT USUALLY HAS AND POPPED OFF. THIS RESULTED IN SOME OF THE PATIENT'S BLOOD SPILLING OUT OF THE SYRINGE. THEY OPENED ANOTHER ACP SERIES 1 KIT AND REDREW THE BLOOD FROM THE LEFT HAND INSTEAD AND COMPLETED THE BLOOD DRAW, SPIN AND INJECTION WITHOUT FURTHER ISSUE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676617 ↗
• MalfunctionMay 9, 2022Fluid/Blood Leak

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10010S DOUBLE SYRINGE SYSTEM IS LEAKING. THIS OCCURRED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337550 ↗
• MalfunctionMar 28, 2022Fluid/Blood Leak

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10010S ACP SYRINGE LEAKED BLOOD OUT WHERE THE SMALL SYRINGE THREADS INTO THE LARGER ONE. THE EXPERIENCED RN FELT IT WAS THREADED IN SECURELY BUT IT STILL LEAKED. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928969 ↗
• MalfunctionNov 16, 2021Fluid/Blood Leak; Detachment of Device or Device Component

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AN ABS-10010S ACP DOUBLE SYRINGE BECAME LOOSE AND ALL THE BLOOD CAME OUT. THE FACILITY HAD TO RESTART THE PROCESS WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819439 ↗
• MalfunctionNov 15, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10010S DOUBLE SYRINGE DID NOT WORK AS INTENDED AND SYRINGE EXPLODED. THIS WAS DISCOVERED DURING A PROCEDURE; PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814388 ↗
• MalfunctionOct 26, 2021Crack

  ON 10/6/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN ABS-10010S SYRINGE CRACKED DURING A BLOOD DRAW. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697583 ↗
• MalfunctionOct 26, 2021Fluid/Blood Leak; Retraction Problem; Unintended Movement

  ON (B)(6) 2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT THE SYRINGE ABS-10010S WAS EXCESSIVELY DIFFICULT TO PULL UPON DURING THE BLOOD DRAW. THEN THE INNER SYRINGE ¿POPPED¿ OUT AND SPILLED BLOOD AFTER THE DRAW. THIS OCCURRED BEFORE SPINNING THE SAMPLE.

  Patient problems: Insufficient Information

  MAUDE report 12697180 ↗
• MalfunctionOct 12, 2021Fluid/Blood Leak

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN ABS-10010S DOUBLE SYRINGE LEAKED RPR FROM PLUNGER DURING INJECTION. THIS WAS DISCOVERED DURING PRP THERAPY. SURGEON COMPLETED CASE SUCCESSFULLY USING ANOTHER DOUBLE SYRINGE; PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616631 ↗
• MalfunctionOct 5, 2021Fluid/Blood Leak

  ON (B)(6) 2021 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN ABS-10010S DOUBLE SYRINGE LEAKED PRP FROM PLUNGER DURING INJECTION. THIS WAS DISCOVERED DURING A PRP THERAPY PROCEDURE, SURGEON USED A NEW DOUBLE SYRINGE TO COMPLETE CASE. NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576862 ↗
• MalfunctionAug 25, 2021Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE, BLOOD LEAKED FROM THE CAP AT THE TIP. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT WITH NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12364428 ↗
• MalfunctionMay 24, 2021Mechanical Problem; Material Separation; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE ABS-10010S SYRINGE FELL APART RIGHT AFTER THE SPIN CYCLE AND THE BLOOD FELL ON THE FLOOR. IT APPEARED THAT THE INNER STRING WOULD NOT SCREW IN PROPERLY AND WOULD NOT TIGHTEN. THE PRODUCT WAS THROWN AWAY AND A NEW KIT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 11872446 ↗
• InjuryApr 20, 2021Fluid/Blood Leak; Device Slipped

  IT WAS REPORTED THAT THE INNER SYRINGES CAME OUT OF THE ABS-10010S WHILE COLLECTING BLOOD. THE FACILITY REPORTED THAT SOME BLOOD DID LEAK OUT OF THE SYRINGES. THERE WERE NO AIR BUBBLES, AND NO ANTI-COAGULANT WAS USED. A NEW KIT HAD TO BE OPENED.

  Patient problems: Insufficient Information

  MAUDE report 11692538 ↗
• MalfunctionJan 11, 2021Fluid/Blood Leak

  IT WAS REPORTED THAT THE ARTHREX ACP® DOUBLE SYRINGE SYSTEM, ABS-10010S, WAS LEAKING WHILE COLLECTING BLOOD. NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146958 ↗
• InjuryNov 16, 2020Leak/Splash

  IT WAS REPORTED THAT THE ABS-10010S PRP KIT SEEMED TO BE FAULTY DURING USE. AS THE PHYSICIAN WAS TRYING TO USE THE DEVICE FOR AN INJECTION, IT CONTINUOUSLY LEAKED OUT OF THE TOP OF THE SYRINGE AS THEY WERE TRYING TO INJECT. THE PHYSICIAN STATED THERE WERE INJECTING UNDER PRESSURE (INTO SPACES WITH RESISTANCE / NOT MUCH TISSUE). ADDITIONAL INFORMATION OBTAINED 11/4/20: THE FLUID LEAKED OUT OF THE TOP OF THE SYRINGE, WHICH WAS HOW IT WAS FIRST NOTICED THAT SOMETHING WAS OFF. IT CAME BETWEEN THE PLUNGER AND THE SEAL OF THE SYRINGE. FLUID LEAKED ONTO STAFF MEMBER'S HAND AND THE STAFF MEMBER THOUGH PERHAPS THEY HAD SQUIRTED IT BETWEEN INJECTIONS. THIS OCCURRED AFTER THE SYRINGE WAS SPUN. I CAME INTO CONTACT WITH THE STAFF MEMBER'S GLOVED HAND AND NOTHING ELSE. THE GLOVES WERE CHANGED AND THE SURFACE ON THE FLOOR UNDERNEATH WAS CAVI-WIPED. THE PATIENT WAS RECEIVING INJECTIONS INTO HIS DERMIS AROUND HIS SCALP FOR THE TREATMENT OF PSORIASIS AND DAMAGE FROM EXCESSIVE CORTICOSTEROID TREATMENT. THE PROCEDURE WAS PERFORMED IN THE SURGEON'S CLINIC AND THE PROCEDURE WAS NOT COMPLETED. INJECTIONS WERE CEASED ONCE THE FLUID LEAK WAS UNDERSTOOD. PATIENT INJECTIONS WERE CONTINUED IN 2 WEEKS AND PATI

  Patient problems: Insufficient Information

  MAUDE report 10843320 ↗
• InjuryNov 4, 2020Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A (B)(6) 2020 PRP INJECTION PROCEDURE IN THE PHYSICIAN'S OFFICE THE ABS-10010S (LOT 0164104413) INNER SYRINGE CAME APART/ BROKE OFF. BLOOD LEAKED OUT AND SPILLED ONTO THE FLOOR, CHAIR AND PATIENT. TO COMPLETE THE PROCEDURE A NEW KIT WAS OPENED. THE DEVICE WAS DISCARDED AT TIME OF PROCEDURE DUE TO BEING COVERED IN BLOOD.

  Patient problems: Blood Loss

  MAUDE report 10785992 ↗