Arthrex® ABS-10011TRecalls & reported problems
Arthrex, Inc. · ACP + ACD-A Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867316539), received between May 18, 2021 and May 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
Device problems
- Fluid/Blood Leak1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2021Fluid/Blood Leak; Structural Problem
IT WAS REPORTED THAT THE SEAL ON THE ABS-10011T DOUBLE SYRINGE WAS COMPROMISED. PRP WAS TO BE INJECTED AT THE END OF THE OPERATIVE FOOT PROCEDURE, BUT THE DOCTOR WAS NOT INTERESTED IN WAITING FOR A NEW BLOOD DRAW AND SPIN. THE REP REPORTED THERE WAS BLOOD ON THE OUTER TIP OF THE SYRINGE. THE REP STATED IT IS HARD TO TELL IF THE FLUID LEAKED OUT OF THE TIP, OR LEAKED OUT OF A COMPROMISED PART OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11841503 ↗
Other Platelet and plasma separator for bone graft handling devices
- Arthrex® ABS-10061TArthrex, Inc. · Platelet and plasma separator for bone graft handling75 reports
- Arthrex® ABS-10060RArthrex, Inc. · Platelet and plasma separator for bone graft handling66 reports
- Arthrex® ABS-10060Arthrex, Inc. · Platelet and plasma separator for bone graft handling59 reports
- Arthrex® ABS-10011Arthrex, Inc. · Platelet and plasma separator for bone graft handling51 reports
- Arthrex® ABS-10063Arthrex, Inc. · Platelet and plasma separator for bone graft handling49 reports
- Arthrex® ABS-10062TArthrex, Inc. · Platelet and plasma separator for bone graft handling35 reports
- Arthrex® ABS-10080Arthrex, Inc. · Platelet and plasma separator for bone graft handling9 reports
- Arthrex® ABS-2016-02Arthrex, Inc. · Platelet and plasma separator for bone graft handling7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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