Arthrex® AR-5068-45LRecalls & reported problems
Arthrex, Inc. · SUTRLASSO SD SFT,45°LFT CRV,R · Class 1
Data updated Oct 18, 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 00888867035614), received between Apr 11, 2022 and Dec 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-5068-45L LEFT CURVE, REUSABLE SUTURELASSO WAS DAMAGED. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23805263 ↗MalfunctionDec 5, 2024Break; Break
ON 11/06/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-5068-45L SUTURELASSO¿ SD SHAFT, 45° LEFT CURVE, HAD THE LASSO TIP BREAK OFF WHILE ATTEMPTING TO PASS THROUGH THE SHOULDER LABRUM. ALL PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE ON 11/06/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853511 ↗MalfunctionApr 11, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY NURSE VIA MEDWATCH MAILED IN LETTER THAT AN AR-5068-45L SUTURELASSO SD SHAFT BROKE INTO TWO PIECES INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC LABRUM REPAIR OF RIGHT SHOULDER ON (B)(6) 2022. AT THIS TIME, IT IS UNKNOWN IF THE BROKEN FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT. LOT NUMBER IS ALSO UNKNOWN, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14075096 ↗
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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 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.
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