Arthrex® ABS-10062K-TH13OTARecalls & reported problems
Arthrex, Inc. · W/ ACD-A 13G OPEN TIP BMA ANGEL KIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867387331), received between Jan 22, 2024 and Jan 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionJan 22, 2024Material Puncture/Hole; Material Puncture/Hole
ON 12/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN OPEN TIP BMA KIT, ABS-10062K-TH13OTA, WAS RECEIVED WITH A HOLE IN THE TUBING; NOT ALLOWING FOR THE BLOOD TO BE DRAWN INTO THE CASSETTE. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556444 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page