Arthrex BioExpress ABS-10053-10Recalls & reported problems
Micromedics, Inc. · Graft Delivery Device · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815634020337), received between Jan 18, 2022 and Feb 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE BLACK NIPPLE FROM AN ABS-10053-10 BIOXPRESS GRAFT DELIVERY, CAME OFF WHEN INJECTING. THE NIPPLE COULD NOT BE FOUND, AND IT WAS LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 18746616 ↗MalfunctionJan 18, 2022Detachment of Device or Device Component
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN ABS-10053-10 BIOXPRESS GRAFT DELIVERY, BLACK RUBBER TIP, FELL OF DEVICE AND INTO THE PATIENT. SURGEON INSERTED A SCOPE AND WAS ABLE TO LOCATE THE BLACK TIP AND RETRIEVE IT. THIS WAS DISCOVERED DURING A SUBTALAR FUSION PROCEDURE ON (B)(6) 2021. CASE WAS COMPLETED SUCCESSFULLY WITHOUT ISSUES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13281885 ↗
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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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