Arthrex® AR-2324KBCCRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867351288), received between Jun 28, 2021 and Aug 31, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (18 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518896 ↗
• MalfunctionNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/04/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR PULLED OUT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025 WHEN ENGAGING THE KNOTLESS MECHANISM THE ANCHOR PULLED OUT. ALL PORTIONS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A 5.5 SWIVELOCK THAT WAS INSERTED INTO THE SAME PRE PUNCHED HOLE THAT WAS PREPPED USING A PUNCH. THE PATIENT HAD A GOOD BONE QUALITY. THERE WAS A DELAY OF ABOUT TWO MINUTES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630375 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR EXPERIENCED AN ISSUE DURING A SUPRASPINATUS DOUBLE-ROW REPAIR. AFTER INSERTION OF THE SECOND LATERAL ROW, A DOG-EAR WAS IDENTIFIED ANTERIORLY. THE REPAIR STITCH FROM THIS ANCHOR WAS PASSED THROUGH THE DOG-EAR AND SUBSEQUENTLY SHUTTLED THROUGH THE ANCHOR. WHILE TENSIONING THE REPAIR SUTURE, THE EYELET DETACHED FROM THE ANCHOR BODY, WITH THE REPAIR SUTURE STILL ATTACHED (SEE PHOTO ATTACHED). DESPITE THIS, THE SUTURES FROM THE MEDIAL ROW WERE APPROPRIATELY TENSIONED, AND THE ANCHOR BODY REMAINED SEATED WITHIN THE BONE. NO ADDITIONAL PARTS WERE USED. THE CASE WAS DELAYED TWO MINUTES TO REMOVE THE EYELET AND SUTURES. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/30/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451678 ↗
• MalfunctionOct 29, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-2324KBCC, BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, 4.75 X 19.1 MM, VE5, THE SWIVELOCK EYELET CUT THROUGH THE SUTURE. THE SURGEON UTILIZED 1.3 MM SUTURETAPE TO CREATE A CABLE CONSTRUCT OVER THE ROTATOR CUFF PRIOR TO PERFORMING THE TUBEROPLASTY. WHILE SECURING THE POSTERIOR PORTION OF THE CONSTRUCT USING AN AR-2324KBCC SWIVELOCK, THE SUTURETAPE WAS CLEANLY SEVERED DURING INSERTION. THE CUT APPEARED PRECISE, THOUGH IT IS UNCLEAR WHETHER IT OCCURRED WITHIN THE EYELET OR ELSEWHERE DURING THE SWIVELOCK DEPLOYMENT. THE SURGEON PROCEEDED BY REPLACING BOTH THE SWIVELOCK AND THE SUTURETAPE ON THE POSTERIOR SIDE WITHOUT FURTHER ISSUES. LATER IN THE PROCEDURE, WHILE SECURING THE ANTERIOR PORTION OF THE CABLE CONSTRUCT USING AN AR-2324KBCC SWIVELOCK, THE SAME ISSUE OCCURRED¿THIS TIME DURING THE IMPACTION PHASE. FORTUNATELY, THE SWIVELOCK REMAINED INTACT AND REUSABLE. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE INVOLVING A TUBEROPLASTY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED ADDITIONAL SUTURES, THE SURGEON ADAPTED BY TYING THE SUTURETAPE TO THE ROTATOR CUFF US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413123 ↗
• MalfunctionOct 23, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-2324KBCC, BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, 4.75 X 19.1 MM, VE5, THE SWIVELOCK EYELET CUT THROUGH THE SUTURE. THE SURGEON UTILIZED 1.3 MM SUTURETAPE TO CREATE A CABLE CONSTRUCT OVER THE ROTATOR CUFF PRIOR TO PERFORMING THE TUBEROPLASTY. WHILE SECURING THE POSTERIOR PORTION OF THE CONSTRUCT USING AN AR-2324KBCC SWIVELOCK, THE SUTURETAPE WAS CLEANLY SEVERED DURING INSERTION. THE CUT APPEARED PRECISE, THOUGH IT IS UNCLEAR WHETHER IT OCCURRED WITHIN THE EYELET OR ELSEWHERE DURING THE SWIVELOCK DEPLOYMENT. THE SURGEON PROCEEDED BY REPLACING BOTH THE SWIVELOCK AND THE SUTURETAPE ON THE POSTERIOR SIDE WITHOUT FURTHER ISSUES. LATER IN THE PROCEDURE, WHILE SECURING THE ANTERIOR PORTION OF THE CABLE CONSTRUCT USING AN AR-2324KBCC SWIVELOCK, THE SAME ISSUE OCCURRED¿THIS TIME DURING THE IMPACTION PHASE. FORTUNATELY, THE SWIVELOCK REMAINED INTACT AND REUSABLE. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE INVOLVING A TUBEROPLASTY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED ADDITIONAL SUTURES, THE SURGEON ADAPTED BY TYING THE SUTURETAPE TO THE ROTATOR CUFF US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366967 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 07/24/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR HAD THE ENTIRE KNOTLESS MECHANISM POP OUT OF THE ANCHOR AS A FAILURE. THIS OCCURRED DURING A CASE. THE ANCHOR BODY ITSELF IS STILL IN THE PATIENT, BUT THE KNOTLESS MECHANISM IS NOT A PART OF THE ANCHOR AT ALL, THE SUTURE WAS RETRIEVED. THIS WAS AN OLDER PATIENT WITH DECENT BONE QUALITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22773002 ↗
• MalfunctionOct 15, 2024Break; Positioning Failure; Break; Positioning Failure

  ON 10/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WOULD NOT ENGAGE WITH THE PATIENT'S BONE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER 324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456331 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 3/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE SWIVELOCK KNOTLESS MECHANISM WAS BROKEN. THE SURGEON DECIDED TO USE THE SUTURES AND CREATE BONE TUNNELS TO DO THE REPAIR INSTEAD. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19484582 ↗
• MalfunctionJun 7, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 1/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR EYELET WAS BENT. THIS WAS DISCOVERED A ROTATOR CUFF REPAIR ON (B)(6) 2023 WHEN THE SURGEON WAS ATTEMPTING TO INSERT THE DEVICE INTO THE PUNCH HOLE. THE CASE WAS COMPLETED BY USING A NEW AR-2324KBCC WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483970 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/07/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR BROKE. THIS OCCURRED DURING A LET PROCEDURE ON (B)(6) 2024 DURING INSERTION, THE ANCHOR BROKE, AND ALL FRAGMENTS WERE RETRIEVED. ANOTHER SWIVELOCK WAS USED AND WORKED PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 19461291 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT THE RETENTION STITCHES ON A QUANTITY TWO AR-2324KBCC BROKE WHILE REMOVING THE INSERTER OUT OF THE CANNULA. THE RETENTION STITCHES BROKE AND WERE STUCK IN THE INSERTER. ONE IMPLANT WAS REMOVED AND THE SECOND IMPLANT REMAINED WHOLE WITHIN THE PATIENT AND THE RETENTION SUTURES WERE REMOVED. THE CASE WAS COMPLETED BY USING ANOTHER SWIVELOCK. SEE SOURCE DATA ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 19323077 ↗
• MalfunctionApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/29/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-2324KBCC KNOTLESS SWIVELOCK PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING A METACARPALS JOINT ARTHROPLASTY PROCEDURE ON (B)(6) 2021. WHEN SURGEON ATTEMPTED TO PULL THE SHUTTLING STITCH THAT PULLS THE REPAIR STITCH THROUGH THE ANCHOR, IT GOT STUCK. WHEN SURGEON APPLIED A BIT MORE OF FORCE, THE ANCHOR PULLED OUT. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES USING A REGULAR 5.5MM SWIVELOCK AND INSERTER IN THE SAME PREVIOUSLY PREPARED BONE HOLE.

  Patient problems: Insufficient Information

  MAUDE report 19193878 ↗
• MalfunctionApr 9, 2024Crack; Crack

  ON 3/19/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06517821 THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK PREMATURELY CRACKED AND COULD NOT BE USED. THE ANCHOR CRACKED BUT DID NOT BREAK COMPLETELY INTO PIECES. ANOTHER IMPLANT HAD TO BE OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19072137 ↗
• MalfunctionMar 11, 2024Defective Device; Defective Device

  ON 2/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK MECHANISM LOCKED UP AND WOULD NOT TENSION. THE SURGEON ENDED UP CUTTING THE REPAIR SUTURES AND REMOVING THE ANCHOR. THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18876986 ↗
• MalfunctionDec 15, 2023Break; Break

  ON 11/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK BROKE. THIS OCCURRED DURING A SHOULDER ROTATOR CUFF REPAIR WHERE THEY LOADED THE SUTURES, AND WHEN THE PEAK EYELET MADE CONTACT WITH THE BONE THE TIP BROKE OFF BEFORE MALLETING. THE FRAGMENT WAS RETRIEVED. THE PATIENT HAD STANDARD BONE IT WASN¿T SOFT OR HARD AND THE BONE WAS NOT VERY DENSE. NO INSTRUMENT WAS USED TO PREPARE THE BONE SOCKET, JUST A REGULAR PUNCH. THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCC.

  Patient problems: Insufficient Information

  MAUDE report 18340834 ↗
• MalfunctionDec 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A BIOCOMPOSITE KNOTLESS SWIVELOCK, AR-2324KBCC, WAS BEING USED IN A PROCEDURE. WHEN PUTTING THE ANCHOR INTO THE PUNCHED BONE TUNNEL, THE TWO FIBERTAPES THAT WERE IN THE EYELET, RIPPED THROUGH THE EDGE OF THE PEEK EYELET. THE SURGEON REPLACED WITH AN AR-2324BCC, WITH LOT# 11772467. NO FRAGMENTS WERE LEFT IN THE PATIENT FROM THE BROKEN EYELET PIECE AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300034 ↗
• MalfunctionSep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR PULLED OUT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023, WHEN THE KNOTLESS MECHANISM GOT HUNG UP AND PULLED THE ANCHOR OUT. THE CASE WAS COMPLETED USING 2 ADDITIONAL ARTHREX ANCHORS. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17759481 ↗
• MalfunctionSep 6, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR HAD AN ISSUE. DURING A SHOULDER ARTHROSCOPY WITH A ROTATOR CUFF REPAIR PROCEDURE, WHEN THE ANCHOR WAS BEING INSERTED, THE EYELET BROKE OFF INSIDE THE PATIENT, AND ALL FRAGMENTS WERE REMOVED. ANOTHER AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. A SLIGHT CASE DELAY OF 5 MINUTES WAS REPORTED. THE DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO PATIENT HARM.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689626 ↗
• MalfunctionAug 24, 2023Material Frayed; Material Frayed

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WAS USED, AND THE KNOTLESS MECHANISM WAS FRAYED UPON OPENING THE PACKAGE AND BROKE WHEN ATTEMPTING TO USE IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 8/7/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA EMAIL: THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE AFTER THE INSERTION OF THE IMPLANT. ALL FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WITH THE SAME LOT NUMBER, THE SURGEON DID NOT USE THE KNOTLESS MECHANISM. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND NO DELAY TO THE SURGERY. THE DEVICE WAS NOT AVAILABLE FOR RETURN, AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613483 ↗
• MalfunctionJul 28, 2023Break; Break

  ON 06/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCC ANCHOR BROKE AT THE FIRST TWO THREADS AFTER BEING MALLETED IN AND TENSION WAS APPLIED WITH DRIVER. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE, ALL FRAGMENTS REMOVED. CASE COMPLETED USING OTHER ANCHORS AND RE-TAPPING.

  Patient problems: Insufficient Information

  MAUDE report 17417528 ↗
• MalfunctionJul 14, 2023Break; Break

  ON 6/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK LOCKING MECHANISM INSIDE THE SWIVELOCK WAS BROKEN WHEN PASSING. THE SURGEON WAS ABLE TO IMPLANT THE ANCHOR. THIS WAS DISCOVERED DURING AN MCL REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17323971 ↗
• MalfunctionJun 22, 2023Break; Break

  ON 6/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK GREEN INSERTER STARTED TO WARP AND BREAK WHEN THE ANCHOR MET THE BONE. THE SURGEON WAS UNABLE TO INSERT THE ANCHOR AS IT WAS SPINNING IN THE BONE DUE TO THE SHAFT BREAKING. THE BROKEN FRAGMENTS WERE RETRIEVED AND A NEW AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK, FROM A DIFFERENT LOT NUMBER, WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182032 ↗
• MalfunctionApr 21, 2023Break; Break

  ON 3/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK PEEK EYELET BROKE DURING INSERTION. ALL THE FRAGMENTS WERE REMOVED, AND CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) 2023.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785364 ↗
• MalfunctionJan 30, 2023Break; Material Twisted/Bent; Break

  ON 1/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR CAME OUT WITHOUT THE EYELET AFTER IMPLANTATION. AN AR-2324BCC BIOCOMPOSITE SWIVELOCK FAILED DURING INSERTION AND THE EYELET WAS LEFT IN THE SOCKET. AN AR-3632SP FIBERTAK SP INSERTER BENT DURING INSERTION. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 16263299 ↗
• MalfunctionJan 23, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-2324KBCC KNOTLESS SWIVELOCK EYELET BROKE OFF. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023 WHEN THE EYELET BROKE OFF AND RELEASED THE SUTURES. THE BROKEN FRAGMENT, AND THE SUTURES WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCC. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223306 ↗