Arthrex® ABS-10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867286580), received between Feb 7, 2022 and Feb 27, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Blocked Connection

  IT WAS REPORTED THAT DURING THE AUTOCART KNEE PROCEDURE, THE FILTER OF THE THROMBINATOR BECAME CLOGGED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE PROCEDURE 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 PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474717 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCART KNEE SURGERY THE FILTER OF THE THROMBINATOR¿ SYSTEM BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE TREATMENT WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632301 ↗
• MalfunctionJan 16, 2025Output Problem; Output Problem

  ON (B)(6) 2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN ABS-10080 THROMBONATOR HAD BLOOD CLOTTED IN THE DEVICE. THE BLOOD DID NOT CLOT AFTER 20 MINUTES OF SITTING IN THE SYRINGE AND DID NOT CLOT WHEN THEY WITHDREW IT. AT THE END OF THE CASE, THE BLOOD RAN COMPLETELY UNCLOTTED WHEN THEY POURED IT OUT WHILE LIFTING THE PACKAGING. THEY STATED THEY FOLLOWED STEP-BY-STEP PROTOCOL FOR WHOLE NONANTICOAGULATED BLOOD AND DID NOT DRAW FROM AN IV LINE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/30/2024: THE BLOOD DID NOT LEAK OUT OF THE ABS-10080 THROMBINATOR. THE CASE WAS COMPLETED USING TISSEEL (FIBRIN GLUE) FROM THE FACILITY'S STOCK. THE CASE WAS DELAYED TWENTY MINUTES TO WAIT FOR THE BLOOD TO CLOT. THEN, THERE WAS ADDITIONAL TIME WAITING FOR THE TISSEEL TO THAW. AT THE END OF THE CASE, THE DEVICE WAS DISCARDED, AND ALL THE BLOOD WAS PULLED BUT NEVER CLOTTED IN THE SYRINGE. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT. THIS OCCURRED IN A PROCEDURE WITH ANESTHESIA DURING A TALAR OCD USING THE THROMBINATOR TO TOP BIOCARTILAGE ON (B)(6)2004.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168941 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCARD PROCEDURE THE SURGEON JUST TOUCHED THE DEVICE AND IT BROKE IN 2 HALVES. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797835 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCART PROCEDURE THE FILTER BROKE AND THE DEVICE COULD NOT BE USED ANYMORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352942 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCART SURGERY THE FILTER BROKEN OFF WHEN TURNED ON OUTSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948575 ↗
• MalfunctionJun 3, 2024Defective Device; Defective Device

  ON (B)(6)/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN ABS-10080 THROMBINATOR DID NOT PROPERLY COAGULATE. THIS WAS DISCOVERED DURING A MENISCUS REPAIR WITH PRP ON (B)(6)2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447864 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCART PROCEDURE THE FILTER OF THE DEVICE BROKE OFF. THE PART BROKE OUTSIDE OF THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014241 ↗
• 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 SURGERY WAS FINISHED SUCCESSFULLY BY DOING A PRIDIE DRILLING. IT WAS NOT NECESSARY DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472052 ↗