Arthrex® AR-8850Recalls & reported problems
Arthrex, Inc. · C-LINE ENDOSCOPIC SOFT TISS REL INST · Class 1
Quick summary
This Arthrex Centerline endoscopic carpal tunnel release instrument is used in surgery to cut tissue. Reports mostly describe blades that are dull, stuck, loose, or unable to cut, and scopes that cannot be fully inserted; some mention numbness or nerve damage. There are 36 reports, 2 injuries, and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00888867048546), received between Aug 24, 2020 and Sep 30, 2026 — classified as 2 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (9 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
- Unintended Movement9
- Material Twisted/Bent8
- Defective Device5
- Physical Resistance/Sticking5
- Positioning Failure4
- Premature Activation3
- Dull, Blunt2
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information4
- Nerve Damage2
- Numbness2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
- Pain1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unintended Movement
On 11-Sep-2026, it was reported by a sales representative via email that an AR-8850 Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during an unspecified carpal tunnel procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947643 ↗MalfunctionSep 30, 2026Unintended Movement
On 11-Sep-2026, it was reported by a sales representative via email that an AR-8850 Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during an unspecified carpal tunnel procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947464 ↗MalfunctionSep 30, 2026Unintended Movement
On 11-Sep-2026, it was reported by a sales representative via email that an AR-8850 Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during an unspecified carpal tunnel procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947297 ↗MalfunctionSep 30, 2026Unintended Movement
On 11-Sep-2026, it was reported by a sales representative via email that an AR-8850 Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during an unspecified carpal tunnel procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947156 ↗MalfunctionSep 29, 2026Material Twisted/Bent
On 11-Sep-2026, it was reported by a sales representative via email that an (b)(6) Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during a carpal tunnel procedure on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934165 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934160 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934149 ↗MalfunctionSep 29, 2026Material Twisted/Bent
On 11-Sep-2026, it was reported by a sales representative via email that an AR-8850 Centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure. It was further noted that the blade appeared to be slightly off kilter. The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position. Troubleshooting included changing scopes, couplers, and Centerline devices. No visible damage, misalignment, bending, or wear was observed. The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage. This was discovered during a carpal tunnel procedure on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934148 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934147 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931389 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931310 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931167 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930968 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930789 ↗MalfunctionSep 18, 2026Use of Device Problem
It was report that during a surgery unable to use the blade on the AR-8850 device due to an issue with the handle. Per complaint reporter there was no harm for patient, operator or third party. No further information received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817254 ↗MalfunctionJul 29, 2026Positioning Failure; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071303 ↗MalfunctionJul 29, 2026Positioning Failure; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071185 ↗MalfunctionJul 27, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035012 ↗MalfunctionMar 5, 2026Physical Resistance/Sticking
ON 12-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8850 C-LINE SOFT TISSUE RELEASE INSTRUMENT BLADE MECHANISM WOULD NOT RETRACT AFTER INITIAL DEPLOYMENT. NO PATIENT WAS HARMED, AND THERE WAS NO PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24520063 ↗MalfunctionNov 17, 2025Premature Activation; Premature Activation
ON 10/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8850 C-LINE SOFT TISSUE RELEASE INSTRUMENT BLADE WAS SLIGHTLY CUTTING THE TRANSVERSE LIGAMENT EVEN WHEN NOT DEPLOYED, WHICH INDICATED THAT THE BLADE MAY HAVE BEEN SLIGHTLY "PROUD." THIS OCCURRED DURING A CASE WITH NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567624 ↗MalfunctionOct 27, 2025Blocked Connection; Optical Obstruction; Blocked Connection; Optical Obstruction
IT WAS REPORTED THAT DURING A SMALL SURGERY THE DM WAS OBSTRUCTED AND THE LENS DID NOT FIT INSIDE, THEREFORE THE DEVICE WAS UNUSABLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389212 ↗MalfunctionSep 12, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
ON 08/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8850 SOFT TISSUE INSTRUMENT HAS A ROUGH SURFACE, NOT SMOOTH. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043177 ↗MalfunctionAug 27, 2025Premature Activation; Premature Activation
ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8850 BLADE IS EXPOSED IN THE TROCAR BEFORE BEING DEPLOYED. IT WAS NOTICED ONCE THE SCOPE IS INSERTED INTO THE ECTR DEVICE, DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22903841 ↗MalfunctionAug 27, 2025Premature Activation; Premature Activation
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8850 BLADE IS EXPOSED IN THE TROCAR BEFORE BEING DEPLOYED. IT WAS NOTICED ONCE THE SCOPE IS INSERTED INTO THE ECTR DEVICE, DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903658 ↗MalfunctionAug 4, 2025Defective Device; Defective Device
IT WAS REPORTED THAT DURING A SURGERY WHEN MOUNTING THE DEVICE, IT WAS IMPOSSIBLE TO CLIP THE OPTICS ONTO THE DEVICE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22699026 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.