Arthrex® ABS-10012Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867001831), received between Feb 15, 2019 and Jul 5, 2022 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Fluid/Blood Leak; Defective Component

  ON 06/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ACP KIT SERIES II HAD AN ISSUE, THE SEAL IN ONE OF THE SYRINGES WAS DEFECTIVE AND LEAKED WHEN DRAWING BLOOD. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 06/22/2022, THE SALES REPRESENTATIVE REPLIED VIA EMAIL AND STATED THE FOLLOWING INFORMATION: THIS EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. NO ANTI-COAGULANT WAS USED AND NO AIR BUBBLES WERE OBSERVED DURING THE BLOOD DRAW. THEY OPENED ANOTHER KIT AND IT WORKED FINE, THE CASE WAS COMPLETED. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914714 ↗
• MalfunctionMar 21, 2022Connection Problem; Device Fell

  ON 3/2/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10012 ACP KIT SERIE II BUTTERFLY NEEDLE WAS NOT PROPERLY HELD BY THE CONNECTOR VALVE DURING THE BLOOD DRAW, CAUSING IT TO FALL OFF AND SPILL THE PATIENT'S BLOOD. THIS CONTAMINATED THE ATTACHMENTS THAT WERE ON THE TABLE. SURGEON OPENED A SECOND KIT TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PRP INJECTION ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13839628 ↗
• MalfunctionJan 11, 2022Fluid/Blood Leak; Misconnection

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10012 ACP KIT HAD TO BE DISCARDED BECAUSE DURING THE SPIN, THE SYRINGES WERE NOT FULLY CONNECTED AND THE PATIENTS BLOOD STARTED TO SPILL OUT OF THE LARGE STRING INTO THE CENTRIFUGE CHAMBER. A NEW KIT WAS OPENED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225554 ↗
• MalfunctionJan 11, 2022Device Slipped; Connection Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10012 ACP KIT HAD TO BE DISCARDED BECAUSE DURING THE SPIN, THE SYRINGES WERE NOT FULLY CONNECTED AND THE PATIENTS BLOOD STARTED TO SILL OUT OF THE LARGE STRING INTO THE CENTRIFUGE CHAMBER. THE STAFF DID NOT FEEL COMFORTABLE WITH USING THE BLOOD AS IT HAD BECOME CONTAMINATED, THEREFORE, PROCEDURE WAS ABORTED. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/21/2021, SALES REPRESENTATIVE CANNOT CONFIRM IF PROCEDURE WAS RESCHEDULE.

  Patient problems: Insufficient Information

  MAUDE report 13225130 ↗
• MalfunctionJun 14, 2021Fluid/Blood Leak; Retraction Problem

  IT WAS REPORTED DURING A KNEE SCOPE PROCEDURE, THREE DIFFERENT STAFF MEMBERS TRIED TO DRAW BLOOD USING THE SYRINGES PROVIDED IN THE ABS-10012 ACP KITS AND TWO OF THE SYRINGES UNTWISTED, SPILLING BLOOD EVERYWHERE. ONE OF THE SYRINGES WAS DRAWING SLOW AND THE STAFF MEMBER WAS HAVING DIFFICULTY PULLING BACK, UNTIL IT SUDDENLY RELEASED PRESSURE AND THE SYRINGE WAS SEPARATED. THE ACP COULD NOT BE DRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991246 ↗
• MalfunctionJun 14, 2021Fluid/Blood Leak; Retraction Problem

  IT WAS REPORTED DURING A KNEE SCOPE PROCEDURE, THREE DIFFERENT STAFF MEMBERS TRIED TO DRAW BLOOD USING THE SYRINGES PROVIDED IN THE ABS-10012 ACP KITS AND TWO OF THE SYRINGES UNTWISTED, SPILLING BLOOD EVERYWHERE. ONE OF THE SYRINGES WAS DRAWING SLOW AND THE STAFF MEMBER WAS HAVING DIFFICULTY PULLING BACK, UNTIL IT SUDDENLY RELEASED PRESSURE AND THE SYRINGE WAS SEPARATED. THE ACP COULD NOT BE DRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991218 ↗
• MalfunctionJun 1, 2021Break; Fluid/Blood Leak

  IT WAS REPORTED THAT BOTH SYRINGES WITHIN ABS-10012 ACP KIT BROKE THE SEAL AND BLOOD WAS NOT CONTAINED WITHIN THE SYRINGE. THE PHYSICIAN HAD TO OPEN TWO SINGLE SYRINGE KITS TO COMPLETE THE PATIENTS APPOINTMENT.

  Patient problems: Insufficient Information

  MAUDE report 11911905 ↗
• InjuryApr 8, 2020Fluid/Blood Leak; Detachment of Device or Device Component

  IN REPORTED DURING AN IN-CLINIC PRP INJECTION, DURING BLOOD DRAW THE INNER SYRINGE WITHIN THE ABS-10012 ACP KIT SERIES II FELL OUT. THE REP REPORTED BLOOD LEAKED OUT OF THE SYRINGE ONTO THE FLOOR. NO INDIVIDUAL CAME INTO CONTACT WITH THE BLOOD. A SECOND ABS-10012 (LOT UNKNOWN) WAS OPENED AND BROUGHT IN TO COMPLETE THE INJECTION WITHOUT FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935143 ↗
• InjuryFeb 25, 2020Crack; Fluid/Blood Leak

  IT WAS REPORTED DURING AN IN-CLINIC PRP LEFT HEEL INJECTION A QUANTITY THREE ABS-10012 ACP KIT SERIES II (LOT: 925697165 X 1 AND LOT: 909492367 X 2) MALFUNCTIONED. THE FIRST SYRINGE CRACKED AND BLOOD LEAKED OUTSIDE OF THE SYRINGE. THE BLOOD LEAKED ONTO THE SYRINGE, AND SOME ALSO LEAKED ONTO THE FLOOR AND ON THE MA'S HAND AS WELL AS THE PATIENT. THE FACILITY REPORTED THE MA WAS WEARING GLOVES, AND ALL SURFACES WERE CLEANED APPROPRIATELY. THE FACILITY REPORTER STATED THEY HAVE THE LATEST USER MANUAL FOR PROPER CLEANING OF BLOOD SPILLS. A SECOND ABS-10012 WAS OPENED AND RIGHT UPON OPENING THE SYRINGE FELL APART COMPLETELY, PRIOR TO BEING USED. A THIRD ABS-10012 WAS OPENED. THE MA ADMINISTERED THE NEEDLE, AND WHILE TRYING TO TAKE THE BLOOD UP, THE BLOOD ONLY CAME UP THE BUTTERFLY LINE AND WOULD NOT GO UP THE SYRINGE. THE INJECTION WAS NOT COMPLETED AND THE PATIENT WILL BE RESCHEDULED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9750674 ↗
• InjuryJan 13, 2020Therapeutic or Diagnostic Output Failure

  THE PATIENT HAS PROVIDED THE FOLLOWING INFORMATION: PATIENT HAD UNDERGONE A LEFT FOOT OSTEOTOMY METATARSAL/LEFT WEIL PLANTAR PLATE REPAIR ON (B)(6) 2017. DURING THE PROCEDURE, AN ARTHREX ACP INJECTION SYSTEM (ACP KIT SERIES II, ABS-10012, LOT 616565204, QTY 2) WAS UTILIZED AND 2 ARTHREX QUICK FIX SCREWS WERE IMPLANTED (AR-8930-11, LOT 10111019). THE FOLLOWING ARTHREX PRODUCTS WERE ALSO USE: AR-13930DS (LOT 703771055) MENISCAL VIPER REPAIR KIT AND AR-8690DS (LOT 10091584, QTY 2) IMPLANT SYSTEM, CPR MINI SCORPION DX. AFTER THE LOCAL ANESTHETIC WORE OFF HIS LEFT FOOT FELT LIKE IT WAS ASLEEP AND THE FEELING RADIATED TO JUST ABOVE THE ANKLE BONE. FEELING HAS NOT GONE AWAY SINCE THE SURGERY. CONDITION DOES NOT IMPACT ANY ACTIVITY, EXCEPT IT FEELS STRANGE, OFTEN A DEAD FEELING AND COLD. ONLY EXCEPTION TO FUNCTIONALITY IS PATIENT'S BALANCE WHILE STANDING ON HIS LEFT FOOT ONLY IS SLIGHTLY WORSE THAN THEN STANDING ON HIS RIGHT FOOT. PATIENT HAD REACHED OUT TO THE SURGEON IN EARLY 2019 BUT CHOSE TO FOLLOW UP WITH HIS LOCAL PHYSICIAN WHO REFERRED HIM FOR REVIEW BY A NEUROLOGIST. EMG EXAM WAS CONDUCTED AND MRI'S WERE PERFORMED ON THE LEFT KNEE AND ANKLE. PATIENT RECAP OF TESTING RESULTS: EMG SH

  Patient problems: Nerve Damage

  MAUDE report 9580149 ↗
• InjuryFeb 15, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT A QUANTITY OF TWO ABS-10012, ACP KIT SERIES II FROM LOT 820785151 LEAKED OUTSIDE OF THE SYRINGE DURING AN IN-CLINIC PROCEDURE. THE ISSUE OCCURRED DURING BLOOD DRAW, AND BOTH THE PATIENT AND STAFF CAME INTO CONTACT WITH THE BLOOD. THE EXPOSED BLOOD WAS CLEANED WITH PAPER TOWELS AND (B)(6) WIPES. THE BLOOD DRAW WAS BEING TAKEN FROM THE ANTECUBITAL FOSSA. THE FACILITY TOOK PICTURES OF THE KITS, AND THEN DISCARDED INTO THE APPROPRIATE DISPOSAL BIN. THE ACCOUNT CONFIRMED THAT THEY HAVE THE LATEST USER MANUAL FOR THE APPROPRIATE CLEANING OF BLOOD SPILLS. THE ACCOUNT STATED IT IS UNKNOWN WHAT CAUSED THE DEVICES TO LEAK, AND THERE WERE NOT ANY NOTICEABLE DAMAGES OR DEFORMITIES WITH EITHER OF THE KITS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344421 ↗