Arthrex® AR-3373-4002Recalls & reported problems
Arthrex, Inc. · SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an Arthrex arthroscopic sheath used with a scope during surgery. The 26 reports mostly describe the sheath breaking, coming apart, slipping out of place, or having a damaged tip; they report no deaths and no injuries. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867198579), received between Feb 14, 2022 and Mar 26, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break9
- Detachment of Device or Device Component4
- Defective Device2
- Device Damaged by Another Device2
- Device Dislodged or Dislocated2
- Material Twisted/Bent2
- Connection Problem1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Unintended Movement
ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH WILL NOT LOCK INTO PLACE AND CONTINUES TO SLIDE UP AND DOWN. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700747 ↗MalfunctionDec 22, 2025Device Damaged by Another Device; Device Damaged by Another Device
ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH HAS A DAMAGED TIP, WAS HIT BY A BURR. FOUND DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862885 ↗MalfunctionDec 10, 2025Device Damaged by Another Device; Device Damaged by Another Device
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH WAS BURRED THROUGH. HAPPENED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767501 ↗MalfunctionJun 20, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
ON 30TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN FOR AR-3373-4002, SHEATH, HF, TAP/FEN, 2 STOPCOCK FOR 4.0 MM SCOPE, THE SHEATH WAS FAULTY. THE OBTURATOR WAS PULLING OUT OF SHEATH. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. THE DEVICE WAS CHECKED AFTER THE PROCEDURE. (REQUESTING FURTHER INFORMATION FROM COMPLAINT INITIATOR).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22297107 ↗MalfunctionMar 21, 2025Defective Device; Sharp Edges; Defective Device; Sharp Edges
IT WAS REPORTED THAT DURING A SAS SURGERY THE SHAFT IS TOO CHARP AND A DAMAGE TO THE CARTILAGE APPEARED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21666575 ↗MalfunctionFeb 13, 2025Break; Break
ON 01/23/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH IS BROKEN. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECTS AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21373248 ↗MalfunctionJan 3, 2025Break; Break
ON 12/04/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH WAS BROKEN WHERE IT CONNECTS TO THE RECEIVER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072037 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT DURING A HAS SURGERY WHEN USING THE DEVICES AR-3373-4002 AND AR-6430 (LOT: 408037) THE LUERLOCK BROKE OPEN AND THE PIN GOT STUCK. THE DEVICE FELL APART INTO INDIVIDUAL PARTS. 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 21047909 ↗MalfunctionDec 10, 2024Break; Break
ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06709948 THAT AN AR-3373-4002 SHEATH HAS A STOPCOCK THAT BROKE OFF. NO CASE INVOLVEMENT INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895748 ↗MalfunctionOct 4, 2024Break; Break
ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AR-8330H SN (B)(6) - BUTTONS DON¿T WORK WHEN PLUGGED INTO CONSOLE. DISCOVERED DURING A CASE, NO ADVERSE AFFECTS ON PATIENT. PUMP REMOTE AR-6482 SN (B)(6) - CERTAIN BUTTONS DON¿T WORK, RUN/STOP OR PRESSURE DOWN. DISCOVERED DURING A CASE, NO ADVERSE AFFECTS ON PATIENT. SCOPE AR-3350-4030 SN (B)(6) - SCRATCH AND/OR CRACK ON LENS. DISCOVERED DURING A CASE, NO ADVERSE AFFECTS ON PATIENT. SHEATH AR-3373-4002 SN LOT# (B)(6) - (SALES ORDER (B)(4) WELD IS BROKEN, PICTURES ATTACHED. DISCOVERED DURING A CASE, NO ADVERSE EFFECTS ON PATIENT. FOOT PEDAL AR-8310 SN (B)(6) - PEDALS NOT WORKING. DISCOVERED DURING A CASE, NO ADVERSE EFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369501 ↗MalfunctionOct 4, 2024Break; Break
ON 27TH SEPTEMBER 2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3373-4002, SHEATH, HF, TAP/FEN, 2 STOPCOCK FOR 4.0 MM SCOPE, THE VALVE BROKE. THIS WAS DETECTED DURING USE IN A SHOULDER SURGERY ON (B)(6) 2024 WITH NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE DEVICE WAS CHANGED TO ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20367954 ↗MalfunctionAug 5, 2024Material Twisted/Bent; Material Twisted/Bent
ON 07/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE AR-3373-4002 SHEATH WAS DENTED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19907754 ↗MalfunctionJul 9, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
ON 06/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-3373-4002 SHEATH HAS POOR CONNECTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19703267 ↗MalfunctionJul 2, 2024Break; Break
ON 7TH JUNE 2024 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3373-4002, SHEATH, HF, TAP/FEN, 2 STOPCOCK FOR 4.0 MM SCOPE SUCTION PORT WAS BROKEN. THIS WAS DETECTED DURING USE IN A SHOULDER SURGERY ON (B)(6) 2024 WITH NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE DEVICE WAS CHANGED TO ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19654279 ↗MalfunctionJul 1, 2024Break; Break
IT WAS REPORTED THAT THE SHEATH HAS BROKEN AS SEEN ON THE PICTURE ATTACHED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643197 ↗MalfunctionFeb 15, 2024Positioning Failure; Connection Problem; Positioning Failure; Connection Problem
ON 01/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH STOPCOCK WOULD NOT LATCH TO SCOPE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18713138 ↗MalfunctionJan 11, 2024Leak/Splash; Leak/Splash
ON 12/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN (B)(6) SHEATH SEAL WAS DAMAGED AND CAUSED LEAKING. THIS WAS DISCOVERED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED AND THERE WERE NO ADVERSE EVENTS. THE CASE WAS COMPLETED AS NORMAL, AND THE STAFF RELIED ON THE DRAPE TO COLLECT THE DRIPPING ARTHROSCOPY FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494930 ↗MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 11/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH IS FALLING APART. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18400758 ↗MalfunctionNov 22, 2023Material Twisted/Bent; Material Twisted/Bent
ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH WAS BENT. THIS WAS DISCOVERED DURING THE CASE. THE CASE WAS COMPLETED USING A NEW SCOPE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18191864 ↗MalfunctionNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 10/17/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-4002 SHEATH HAD A STOPCOCK FALL OUT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18140635 ↗MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE STOPCOCK ON THE SHEATH DETACHED AT THE WELD. ACCORDING TO THE SURGEON, NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129226 ↗MalfunctionOct 26, 2023Defective Device; Defective Device
IT WAS REPORTED THAT THE STOPCOCK OF THE SHEATH IS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18013323 ↗MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4). THAT AN AR-3373-4002 SHEATH HAD AN ISSUE. THE CAMERA WOULD NOT SIT ON THE SHEATH AND KEPT COMING OUT DURING THE CASE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17918659 ↗MalfunctionNov 29, 2022Disconnection
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY A PART OF THE DEVICE CAME LOOSE. EVERYTHING WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 15876185 ↗MalfunctionMay 9, 2022Break; Device Slipped
CASE (B)(4) ON (B)(6) 2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF DURING USE, THE WASHER CAME OUT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION 04/25/2022 ON 04/25/2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF AND THE WASHER CAME OUT, DURING USE IN A KNEE PROCEDURE AT LAHEY CLINIC WITH DR. SAMUELSON. THE CASE WAS COMPLETED USING A BACKUP SET. REQUESTED ADDITIONAL INFORMATION ON THE REMOVAL OF BROKEN FRAGMENTS FROM THE PATIENT. ADDITIONAL INFORMATION 04/28/2022 ON 04/28/2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-3373-4002 OBTURATOR SNAP IN HALF AND THE WASHER CAME OUT, DURING USE IN A KNEE PROCEDURE. NOTHING WAS LEFT IN THE PATIENT ALL FRAGMENT WILL BE RETURNED. THE CASE WAS COMPLETED USING A BACKUP SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336141 ↗
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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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