Arthrex® ABS-2016-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867319943), received between Feb 8, 2023 and Aug 25, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Material Puncture/Hole; No Flow; Material Puncture/Hole; No Flow

  ON 08/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN ABS-2016-02 BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE, WHEN THEY WENT TO SPIN THE BMAC, IT WASN¿T PULLING UP THROUGH THE TUBING, AND IT WAS MAKING A SQUEAKING NOISE. THIS OCCURRED DURING A ROTATOR CUFF REPAIR. THEY DETERMINED THAT THERE WAS A HOLE IN THE TUBING, SO THEY CHANGED TO A NEW KIT, TRANSFERRED THE BLOOD TO THE NEW TUBING KIT, AND PROCEEDED.

  Patient problems: Insufficient Information

  MAUDE report 22882778 ↗
• MalfunctionMay 27, 2025Positioning Failure; Positioning Failure

  ON 05/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) ABS-2016-02 BIOSURGE KIT PORTION DID NOT SNAP INTO THE CENTRIFUGE CORRECTLY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089536 ↗
• MalfunctionApr 2, 2024Material Puncture/Hole; Material Puncture/Hole

  ON 03/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-2016-02 BIOSURGE KIT HAD A HOLE IN THE TUBING. THIS OCCURRED DURING A CASE WHERE BLOOD SPILLED.

  Patient problems: Insufficient Information

  MAUDE report 19019799 ↗
• MalfunctionApr 2, 2024Material Puncture/Hole; Material Puncture/Hole

  ON 03/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN ABS-2016-02 BIOSURGE KIT HAD A HOLE IN THE TUBING AND BLOOD SPILLED OUT OF THE KIT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PROCEDURE COMPLETED USING ANOTHER KIT. DELAY IN CASE 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018359 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-2016-02 BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE HAD A HOLE IN THE TUBING PREVENTING THEM FROM BEING ABLE TO USE THAT KIT WITH THE ANGEL MACHINE. THE KIT WAS DISCARDED BECAUSE IT CONTAINED THE PATIENT'S BLOOD. NO NEGATIVE OUTCOME WAS ASSOCIATED WITH THE EVENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698010 ↗
• MalfunctionFeb 8, 2023Fluid/Blood Leak; Difficult to Insert; Device Difficult to Setup or Prepare

  IT WAS REPORTED ON 12/28/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-2016-02 BIOSURGE KIT LEAKS. CASE INVOLVEMENT, NO PATIENT EFFECT. PER FACILITY: "COMPLETING A FACL AND WHEN MIXING THE ALLOSYNC PURE, AUTOLOGOUS BONE FROM THE GRAFTNET AND PRP IN A RATIO OF 5:3-5:1, ALL OF THE LIQUID PRP CAME SQUEEZING OUT, ESSENTIALLY DRYING UP THE BONE GRAFT MATERIAL AND MAKING FOR DIFFICULTY IMPLANTING." CONFIRMED VIA EMAIL ON 1/23/2023 THAT BLOOD DID LEAK FROM THE SYRINGE INTO THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327783 ↗
• MalfunctionFeb 8, 2023Fluid/Blood Leak

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-2016-02 BIOSURGE KIT LEAKS. CASE INVOLVEMENT, NO PATIENT EFFECT. PER FACILITY: "COMPLETING A FACL AND WHEN MIXING THE ALLOSYNC PURE, AUTOLOGOUS BONE FROM THE GRAFTNET AND PRP IN A RATIO OF 5:3-5:1, ALL OF THE LIQUID PRP CAME SQUEEZING OUT, ESSENTIALLY DRYING UP THE BONE GRAFT MATERIAL AND MAKING FOR DIFFICULTY IMPLANTING." CONFIRMED VIA EMAIL ON (B)(6) 2023 THAT BLOOD DID LEAK FROM THE SYRINGE INTO THE STERILE FIELD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323584 ↗