Arthrex® ABS-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867001817), received between Jul 1, 2020 and Mar 11, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Contamination

  IT WAS REPORTED THAT DURING AN AUTO CART (MINCED CARTILAGE) KNEE SURGERY IT WAS NOTICED THAT FOREIGN MATERIAL IS PRESENT IN THE COLLECTED CARTILAGE MATERIAL AFTER IT HAS BEEN INTRODUCED INTO THE INSERTION SLEEVE (NEEDLE, TUOHY). PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. WITH CASE (B)(4) INFORMATION WAS PROVIDED THAT THE SAME ERROR OCCURRED PREVIOUSLY WITH NO FURTHER INFORMATION AVAILABLE, THEREFORE THIS CASE WAS CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567679 ↗
• MalfunctionMar 11, 2026Contamination

  IT WAS REPORTED THAT DURING AN AUTO CART (MINCED CARTILAGE) KNEE SURGERY IT WAS NOTICED THAT FOREIGN MATERIAL IS PRESENT IN THE COLLECTED CARTILAGE MATERIAL AFTER IT HAS BEEN INTRODUCED INTO THE INSERTION SLEEVE (NEEDLE, TUOHY). PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567181 ↗
• MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN AUTOCART PROCEDURE, METAL DEBRIS WAS FOUND IN THE HARVESTED CARTILAGE MASS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 09-OCT-2023 UPDATE DW: FURTHER INFORMATION WAS PROVIDED THAT AFTER THE CARTILAGE IS CUT WITH THE SABRE AR-7300SR AND COLLECTED WITH THE GRAFTNET IT WAS NOTICED THAT NO METAL PARTICLES WERE FOUND IN THE CARTILAGE MASS AT THIS MOMENT. THE METAL ABRASION ONLY BECAME VISIBLE IN THE JOINT WHEN THE CARTILAGE MASS WAS APPLIED, INDICATING THAT THE DEBRIS WAS CAUSED BY THE SYRINGE. THE SURGEON DECIDED TO USE THE MASS WITH THE PARTICLES TO FINISH THE SURGERY SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18001813 ↗
• InjuryFeb 7, 2022Defective Device

  IT WAS REPORTED THAT DURING AN AUTOCART PROCEDURE NO THROMBIN WAS PRODUCED. THE MIXTURE COULD NOT BE PRODUCED BECAUSE THE THROMBIN COULD NOT BE DRAWN FROM THE FILTER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGICAL TECHNIQUE WAS CHANGED TO A PRIDIE DRILLING. BUT THE SURGERY COULD NOT BE FINISHED SUCCESSFULLY. A SECOND SURGERY WILL BE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471864 ↗
• InjuryJul 1, 2020Device Fell

  IT WAS REPORTED THAT THE SECOND SYRINGE DROPPED OUT OF THE DOUBLE SYRINGE WITHOUT ANY TWISTING OR PRESSURE FOLLOWING A BLOOD DRAW, RESULTING IN SPILLAGE OF SPECIMEN FLUID. NO FURTHER INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION OBTAINED 6/16/2020: PROCEDURE WAS A BLOOD DRAW AND PRP INJECTION. THE PROCEDURE WAS PERFORMED IN THE SURGEON'S OFFICE. THE SPILLAGE OF SPECIMEN FLUID WAS CLEANED WITH SANI-WIPES AND DISINFECTANT. THE SPECIMEN FLUID CAME IN CONTACT WITH THE MID-LEVEL PROVIDER WHO WAS USING THE DEVICE, ONLY ON CLOTHING AND ARMS. PROVIDER WAS WEARING GLOVES/PPE. THE FACILITY HAS PROVIDED A LOT NUMBER (930598580) WHICH DOES NOT MATCH THE PART NUMBER PROVIDED (ABS-1001) WITH THE ORIGINAL REPORT. IT HAS BEEN DETERMINED THAT THE CORRECT PART NUMBER IS ABS-10011.

  Patient problems: Exposure to Body Fluids

  MAUDE report 10217837 ↗