Arthrex® ABS-10011Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00888867001824), received between Jul 25, 2017 and Jul 24, 2024 — classified as 20 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN AUTOCRAT SURGERY THE ACP SYRINGE DID NOT WORK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 16-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE 2ND SYRINGE FOR THE FINISHED ACP COULD NOT BE ACTUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817465 ↗
• MalfunctionJul 24, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN AUTOCART SURGERY THE ACP SYRINGE DID NOT WORK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 16-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE 2ND SYRINGE FOR THE FINISHED ACP COULD NOT BE ACTUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817302 ↗
• MalfunctionMar 7, 2024Leak/Splash; Leak/Splash

  ON 02/15/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN ABS-10011 ACP® KITS SYRINGE MALFUNCTIONED, IT BROKE APART, AND BLOOD SPEWED OUT ONTO THE PATIENT, CHAIR, AND ROOM. THIS OCCURRED DURING USE WHILE DRAWING BLOOD. THEY REDREW THE BLOOD USING ANOTHER ABS-10011, AND THE CASE CONTINUED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 02/16/2024, WHERE THE SALES REPRESENTATIVE REPORTED THAT THIS EVENT OCCURRED ON (B)(6) 2024 DURING A BLOOD DRAW. THE SYRINGE MALFUNCTIONED, IT BROKE APART, AND BLOOD SPEWED OUT ONTO THE PATIENT, CHAIR, AND ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856429 ↗
• MalfunctionDec 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER OPENED THREE ACP SYRINGES AND PLACED THE TRACEABILITY LABELS INSIDE THE BOX BUT THE LOT NUMBERS ON THE LABELS DO NOT MATCH THE LOT NUMBERS WHICH ARE ON THE BOX. THE CUSTOMER RECEIVED THE LABELS WITH THE LOTS 3109130897 X 2 + 3072129954 X1 INSTEAD OF THE LOTS 3080130164 X1 AND 3109130899 X 2 WHICH ARE NOTED ON THE BOXES. IT WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340664 ↗
• MalfunctionMay 26, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN ABS-10011 ARTHREX ACP® KITS SYRINGE LEAKED ALL THE BLOOD OUT. THIS OCCURRED DURING A PRP INJECTION ON (B)(6) 2023, WHEN THEY REMOVED THE SYRINGE ALL THE BLOOD LEAKED OUT OF IT AND ANOTHER KIT WAS USED TO COMPLETE THE INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011531 ↗
• MalfunctionMay 2, 2023Leak/Splash; Leak/Splash

  ON 4/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ACP SYRINGE LEAKED. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 4/17/2023: THIS WAS DISCOVERED DURING A PRP INJECTION ON (B)(6) 2023. THE SYRINGE LEAKED BLOOD AND HAD TO REDRAW. ANOTHER ABS-10011 ACP KIT WAS USED TO COMPLETE THE CASE. THE LEAK WAS IN AN OPEN FIELD, BUT NO ONE CAME IN DIRECT CONTACT WITH IT DUE TO WEARING PERSONAL PROTECTIVE EQUIPMENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16854372 ↗
• MalfunctionMay 2, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ACP SYRINGE LEAKED. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 4/17/2023: THIS WAS DISCOVERED DURING A PRP INJECTION ON(B)(6) 2023. THE SYRINGE LEAKED BLOOD AND HAD TO REDRAW. ANOTHER ABS-10011 ACP KIT WAS USED TO COMPLETE THE CASE. THE LEAK WAS IN AN OPEN FIELD, BUT NO ONE CAME IN DIRECT CONTACT WITH IT DUE TO WEARING PERSONAL PROTECTIVE EQUIPMENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16854366 ↗
• MalfunctionApr 21, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP® KIT WHEN DRAWING BACK THE LARGE PLUNGER IT CAME OFF. THIS OCCURRED DURING A CASE ON (B)(6) 2023, THE LARGE PLUNGER CAME OFF, RESULTING IN BLOOD SPILLING OUT THE SYRINGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16785502 ↗
• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  ON 02/23/2023, IT WAS REPORTED BY SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP® KIT HAD BLOOD LEAKING OUT. THIS OCCURRED DURING A CASE WHEN BLOOD STARTED LEAKING OUT, THE KIT WAS THROWN AWAY. THE CASE WAS COMPLETED USING A NEW KIT. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16552670 ↗
• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  ON 02/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP® KIT DID NOT INCLUDE THE LURE CAP WHEN OPENED. THIS OCCURRED DURING A CASE, THE KIT WAS USED REGARDLESS, AND WHEN SPUN BLOOD WENT EVERYWHERE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16552550 ↗
• InjuryMar 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED ON 02/17/2023 BY A DISTRIBUTOR VIA SEMS THAT AN ABS-10011 ACP KIT HAD HOLES IN THE BUTTERFLY NEEDLE TUBING AND LEAKED BLOOD. CASE INVOLVEMENT, EXPOSURE TO BODILY FLUID.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16511643 ↗
• MalfunctionFeb 6, 2023Break

  IT WAS REPORTED ON 01/19/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT NEEDLE BROKE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303251 ↗
• MalfunctionDec 7, 2022Break; Material Separation

  IT WAS REPORTED ON 11/23/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT NEEDLE DISENGAGED FROM DEVICE DURING INJECTION. CASE INVOLVEMENT, BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 15931223 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ARTHREX ACP KIT LEAKED BLOOD BEYOND THE SEAL OF THE PLUNGER WHEN SPUN. THE PATIENT'S BLOOD WAS REDRAWN, AND CASE WAS COMPLETED WITH A NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923360 ↗
• MalfunctionNov 28, 2022Fluid/Blood Leak

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10011 ACP® KITS SYRINGE HAD BLOOD LEAKAGE ONTO TUBE CELL. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868739 ↗
• MalfunctionNov 14, 2022Break; Fluid/Blood Leak; Air/Gas in Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10011 ACP® KITS LUER LOCK ON THE OUTER SYRINGE WAS BROKEN AND CAUSED TOO MUCH AIR TO ENTER THE SYRINGE DURING THE BLOOD DRAW. THIS OCCURRED DURING AN UNKNOWN CASE, ACCORDING TO THE PICTURE ATTACHED, THERE WERE SIGNS THAT BLOOD LEAKED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788208 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Air/Gas in Device

  ON 08/23/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN ABS-10011 ACP KIT SERIES I HAD FAILED DURING USE (2 OUT OF 10). THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 09/16/2022, THE FACILITY REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING INFORMATION: BOTH DEVICES FAILED IN THE SAME PRP PROCEDURE ON (B)(6) 2022. THE 6ML SYRINGE FAILED TO STAY IN PLACE WHILE DRAWING BLOOD AND FELL OUT CAUSING BLOOD TO SPILL. AIR BUBBLES WERE OBSERVED DURING THE BLOOD DRAW. THERE WAS NO IMPACT OR ANY HARM REPORTED TO THE PATIENT OR THE FACILITY STAFF. BOTH DEVICES HAVE BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON HOW THE SITE WAS DECONTAMINATED AND HOW THE CASE WAS COMPLETED. ON 09/26/2022, THE FACILITY REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING INFORMATION: THE SITE WAS DECONTAMINATED AFTER THE BLOOD SPILL BY USING AN EMERGENCY SPILL KIT, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER ABS-10011 ACP KIT SERIES I, A LOT NUMBER WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534271 ↗
• MalfunctionSep 19, 2022Fluid/Blood Leak

  ON 9/2/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT SERIES I HAD AN ISSUE, THE SEAL WAS NOT WORKING PROPERLY AND BLOOD WAS LEAKING. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 09/15/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THIS EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. BLOOD WAS LEAKING WHERE THE SEAL WAS, AND THE PRP COULD NOT BE RETAINED. NO FACILITY STAFF OR PATIENT WAS HARMED, THE AREA WAS DECONTAMINATED AND A NEW ABS-10011 ACP KIT SERIES I, LOT NUMBER UNKNOWN, WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE. THE FACILITY STAFF AND THE PATIENT ARE FINE TO DATE. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445864 ↗
• MalfunctionAug 29, 2022Crack

  ON 08/08/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A ABS-10011 ACP KIT CRACKED IN THE OUTER SYRINGE SYSTEM, AND BLOOD SPILLED OUT. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310934 ↗
• MalfunctionJul 25, 2022Burst Container or Vessel

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT SERIES I EXPLODED DURING AN UNSPECIFIED PROCEDURE. THE PATIENT WAS NOT AFFECTED, ANOTHER ACP KIT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 07/12/2022, THE FACILITY REPRESENTATIVE REPLIED VIA EMAIL AND PROVIDED THE FOLLOWING INFORMATION: THIS EVENT OCCURRED DURING A PRP INJECTION PROCEDURE TO BOTH KNEES ON 06/30/2022. ANTI-COAGULANT WAS NOT USED, BUT AIR BUBBLES WERE OBSERVED DURING THE BLOOD DRAW. WHEN THE KIT EXPLODED, THE NURSES WERE EXPOSED TO BODILY FLUID. THE AREA WAS DECONTAMINATED AFTERWARD AND THE SURGEON, FACILITY STAFF/NURSES, AND PATIENT ARE ALL OK AND FINE TO DATE. ON 07/12/2022, THE FACILITY REPRESENTATIVE STATED THE FOLLOWING ADDITIONAL INFORMATION OVER THE PHONE: THE BAG WITH THE BLOOD JUST POPPED, AND BLOOD WAS EVERYWHERE, THE NURSES WERE DRENCHED, NO ONE PANICKED, AND THE PATIENT WAS NOT AFFECTED. THIS HAPPENED WHEN THEY WERE EXTRACTING, THE NURSES HAVE DONE THIS PROCEDURE FOR A COUPLE OF YEARS AND THIS HAS NEVER HAPPENED BEFORE. EVERYTHING WAS DECONTAMINATED, AND A SECOND BAG WAS USED TO COMPLETE THE PROCEDURE SUCCES

  Patient problems: Exposure to Body Fluids

  MAUDE report 15093479 ↗
• MalfunctionMay 31, 2022Fluid/Blood Leak; Defective Component

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10011 KIT WAS DEFECTIVE, CAUSING A BLOOD SPILL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM OR CASE DELAY REPORTED. REQUESTED ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548342 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak

  ON 3/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ARTHREX ACP KIT SYRINGE WAS ATTACHED TO A BUTTERFLY NEEDLE AND WHEN BLOOD WAS DRAWN, IT DRIPPED OUT OF THE LINE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. A SECOND KIT WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED ON 3/22/2022: THE BLOOD SPILLED FROM THE TUBE NEAR THE SYRINGE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994975 ↗
• MalfunctionMar 28, 2022Leak/Splash

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10011 SYRINGE KIT LEAKS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929183 ↗
• MalfunctionJan 4, 2022Leak/Splash; Separation Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10011 ACP KIT HAD THE INNER SYRINGE POP OUT DURING THE BLOOD DRAW, EVEN AFTER IT WAS TIGHTENED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/23/2021: THIS OCCURRED DURING A KNEE INJECTION PROCEDURE AND SURGEON COMPLETED CASE USING ANOTHER ABS-10011 KIT FROM THE SAME LOT NUMBER WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED 12/23/2021: DURING THE BLOOD DRAW, THE INNER SYRINGE POPPED OUT AND CAUSED A LEAK.

  Patient problems: Insufficient Information

  MAUDE report 13154455 ↗
• MalfunctionNov 8, 2021Coagulation in Device or Device Ingredient; Device Fell; Suction Failure

  ON (B)(6) 2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN ABS-10011 ACP KIT COAGULATED DURING USE. IT WAS REPLACED WITH ANOTHER KIT BUT WHILE IN USE THE BACK OF THE SYRINGE FELL OUT SPILLING BLOOD ONTO THE FLOOR. IT HAD NO SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770660 ↗