Arthrex® AR-8690SLLRecalls & reported problems
Arthrex, Inc. · SUTURE LASSO, PIGTAIL, LEFT CURVED · Class 1
Data updated Oct 16, 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 00888867198401), received between May 16, 2024 and Mar 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
- Mechanical Jam1
- Physical Resistance/Sticking1
Patient problems
- 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.
MalfunctionMar 20, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 11TH MARCH 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-8690SLL SUTURELASSO¿, PIGTAIL, LEFT CURVED, THE PIGTAIL LASSO WIRE WOULD NOT PASS / MOVE FREELY THROUGH DEVICE. THIS OCCURRED DURING USE A PLANTAR PLATE REPAIR ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY AS THEY OPENED A NEW PIGTAIL LASSO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653551 ↗MalfunctionMay 16, 2024Failure to Advance; Failure to Advance
ON 26 APRIL 2024, IT WAS REPORTED BY WAREHOUSE VIA EMAIL THAT FOR AN AR-8690SLL SUTURE LASSO, PIGTAIL, LEFT CURVED THE SURGEON WAS UNABLE TO PASS THE WIRE LOOP THROUGH THE PIGTAIL LASSO. THIS OCCURRED DURING A PLANTAR PLATE REPAIR IN SOUTHERN CROSS HOSPITAL, CHRISTCHURCH. THE CASE WAS COMPLETED SUCCESSFULLY VIA THE USE OF ANOTHER SUTURE LASSO. THERE WAS CASE INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19330778 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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