Arthrex® AR-7234CRecalls & reported problems
Arthrex, Inc. · FIBERLOOP · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867041691), received between Apr 29, 2025 and Sep 8, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON 22ND AUGUST 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-7234C, FIBERLOOP® #2, BRAIDED POLYBLEND SUTURE, BLUE, LOOPED, WITH CURVED NEEDLE, 40'' (101,6 CM), 20'' WORKING LENGTH, THE NITINOL WIRE BROKE FROM SUTURE. THIS WAS DETECTED DURING USE IN A BICEP TENODESIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MAYO NEEDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22998851 ↗MalfunctionSep 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-7234C, FIBERLOOP® #2, BRAIDED POLYBLEND SUTURE, BLUE, LOOPED, WITH CURVED NEEDLE, 40'' (101,6 CM), 20'' WORKING LENGTH, THE NITINOL WIRE BROKE FROM SUTURE. THIS WAS DETECTED DURING USE IN A BICEP TENODESIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MAYO NEEDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22998628 ↗MalfunctionApr 29, 2025Break; Break
ON 04/11/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-7234C FIBERLOOP ISLET BROKE OFF THE SUTURE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928671 ↗
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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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