Arthrex® AR-7506TRecalls & reported problems
Arthrex, Inc. · SUTURETAPE 1.3 BLK/WH W/TPR NDL 36.6MM · Class 2 · Implant
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 00888867341593), received between Jan 30, 2024 and Dec 10, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Break; Break
ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE NEEDLE FROM AN AR-7506T SUTURETAPE POPPED OFF. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/15/2024: THE NEEDLE POPPED OFF WHILE THE SURGEON USED IT ON THE PATIENT DURING A SUB PEC BICEPS TENODESIS PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A NEW AR-7506 SUTURETAPE. THE CASE WAS INSIGNIFICANTLY DELAYED WITH NO ADDITIONAL ANESTHESIA NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892095 ↗MalfunctionJan 30, 2024Defective Device; Defective Device
ON 01/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-7506T SUTURETAPE WAS DEFECTIVE. THIS OCCURRED DURING A CASE UPON BEING OPENED. THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608657 ↗
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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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