Arthrex® AR-6527-07Recalls & reported problems
Arthrex, Inc. · Atraumatic CapsuleCut Blade · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867445703), received between Dec 16, 2025 and Mar 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Dull, Blunt
ON 18-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6527-07 CAPSULE BLADE IS DULL AND HAD TROUBLE CUTTING THROUGH THE CAPSULE. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 3-MAR-2026: DEVICE SWAPPED FOR AR-6527-02C AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567813 ↗MalfunctionMar 11, 2026Dull, Blunt
ON 18-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6527-07 CAPSULE BLADE IS DULL AND HAD TROUBLE CUTTING THROUGH THE CAPSULE. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 3-MAR-2026: DEVICE SWAPPED FOR AR-6527-02C AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567749 ↗MalfunctionDec 16, 2025Dull, Blunt; Dull, Blunt
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-6527-07 CAPSULE BLADES ARE DULL AND AREN'T CUTTING TISSUE EFFECTIVELY. NOTICED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION 12/5/25: MALFUNCTION OCCURRED DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR AND WAS ABLE TO COMPLETE CASE WITH CAPSULE BLADES FROM A DIFFERENT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818181 ↗MalfunctionDec 16, 2025Dull, Blunt; Dull, Blunt
ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6527-07 CAPSULE BLADES ARE DULL AND AREN'T CUTTING TISSUE EFFECTIVELY. NOTICED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION 12/5/25: MALFUNCTION OCCURRED DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR AND WAS ABLE TO COMPLETE CASE WITH CAPSULE BLADES FROM A DIFFERENT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816368 ↗
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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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