Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GRecalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 00801741069789), received between Apr 7, 2017 and Sep 26, 2026 — classified as 43 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (57 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908455 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THAT SOME ARE PACKED TOO TIGHT AND SOME ARE DAMAGED BENT UP. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172969 ↗
• MalfunctionDec 11, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT STATED THAT PACKAGING HAS DEFECTS WHERE HOLES ARE CREATED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778288 ↗
• InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THAT THE PATIENT MENTIONED THE BLEEDING AGAIN THAT HE STATED BEFORE. ONCE HE PUT IN THE COUDE CATH, HE HAD BLEEDING. HE DIDN'T KNOW IT WAS A COUDE CATH AND HAD TO GO TO THE HOSPITAL TO HAVE ALL THE BLOOD DRAINED OUT OF HIS BLADDER. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23770026 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Defective Device; Component Misassembled; Nonstandard Device; Defective Device; Component Misassembled

  PATIENT SAID HE HAD ONE CATHETER THAT WAS FAULTY FROM HIS JUNE ORDER. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, THE PRODUCT IS NOT AVAILABLE, I TRASHED IT. THERE WAS NO WATER IN THE SILVER BAG. NO INTERVENTION REQUIRED. THE BIGGEST CONCERN WAS THAT IT WOULD MAKE ME ONE SHORT AND I CATH EVERY NIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294205 ↗
• InjurySep 18, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THEY HURT HAD BLEEDING WAS NOT LUBED ENOUGH. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23084134 ↗
• MalfunctionAug 15, 2025Component Misassembled; Component Misassembled

  PATIENT SAID THE CATHETER DID NOT HAVE EYELETS. PATIENT REQUESTED FOR NO FOLLOW UP CALL. PATIENT DOES NOT HAVE SAMPLE. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815355 ↗
• MalfunctionJun 27, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN A BAG OF INTERMITTENT CATHETER SAMPLES LAST WEEK AND PATIENT CAME IN TODAY SAYING THAT THEY HAD AN ISSUE WITH ONE OF THE INTERMITTENT CATHETER. THE PATIENT EXPERIENCED A SHARP PAIN AFTER INSERTING IT. PATIENT PULLED IT OUT AND NOTICED THE END OF THE CATHETER WAS SLICED DIAGONALLY AND WAS VERY SHARP. PATIENT ENDED UP HAVING SOME BLEEDING FOR A FEW DAYS. PATIENT HAD NOT NOTICED THAT ISSUE WITH ANY OF THE OTHER SAMPLES, BUT THEY WANTED TO BRING IT TO THEIR ATTENTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 22345163 ↗
• MalfunctionJun 24, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A HARD TIME WITH THE NEW PACKAGING AND MISSED THE ADHESIVE ON THE BACK. THEY PREFERRED THE OLD PACKAGING AND WAS EASIER TO HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320080 ↗
• MalfunctionMar 26, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE LAST SHIPMENT OF MAGIC3 INTERMITTENT CATHETERS WAS ARRIVED AT THE BEGINNING OF FEBRUARY, IN SUB-FREEZING TEMPERATURES. A SMALL NUMBER OF CATHETERS IN THE BOXES. THEY HAVE USED SO FAR HAVE LUBE WHICH WAS THICK AND VISCOUS, AND CLUMPS RATHER THAN SPREADING ALONG THE CATHETER TUBE. IN TOTAL OVER 20 BOXES RECEIVED WAS PROBABLY LESS THAN 1 BOX. THESE CATHETERS SHOULD BE REPLACED, BECAUSE DURING USE THEY WERE NOT COMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 21697901 ↗
• MalfunctionMar 21, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PATIENT HAD 3 BOXES THAT DIDN'T HAVE STICKY SQUARE ON OUTSIDE OF PACKAGE TO STICK CATHETER TO THE WALL. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 19MAR2025, IT WAS REPORTED THAT THEY USED ALL OF THOSE CATHETERS AND DID NOT HAVE THE LOT NUMBERS. NOTHING WAS WRONG WITH THE CATHETERS IT WAS THE PACKAGING. THEY ALSO REPORTED THAT IN THE PAST, THEY HAD CATHETERS THAT WHEN THEY BURST THE LUBRICANT PACK, THE LIQUID LEAKED FROM THE END OF THE PACK THAT THE CATHETERS WAS IN. PATIENT DID NOT HAD THAT ISSUE IN A FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662950 ↗
• MalfunctionMar 12, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT INTERMITTENT CATHETER DID NOT HAVE ENOUGH LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585414 ↗
• MalfunctionMar 12, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PATIENT SAID NONE OF THEM HAD THE STICKER TO HOLD THE INTERMITTENT CATHETER TO THE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583439 ↗
• MalfunctionFeb 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PATIENT UTILIZED MAGIC3 HYDROPHILIC INTERMITTENT CATHETER 53616G.PATIENT STATED THAT THE CATHETER WAS DIFFICULT TO WORK WITH AS THERE WAS NO LUBRICANT WHICH MAKE IT DIFFICULT TO INSERT. PATIENT STATED URINE DID NOT FLOW EVENLY, IT DRIZZLES OUT AND THE ORANGE CAP MOVES UP AND DOWN. PATIENT STATED NO INSTRUCTIONS WERE PROVIDED IN THEIR SHIPMENT. PATIENT ADVISED THEY WOULD PREFER TO GO BACK TO THE OLD CATHETERS BEFORE THESE. REVIEWED MAGIC3 HOW TO GUIDE WITH PATIENT FOR OPENING THE PACKAGE, BREAKING THE WATER PACKET AND WETTING THE CATHETER. ADVISED THE SURE-GRIP SLEEVE ORANGE CAP WAS WHAT THE PATIENT HOLDS WHILE INSERTING THE CATHETER IT SLIDES ALONG THE SHAFT OF THE CATHETER. ADVISED PATIENT TO CONTACT THEIR MEDICAL SUPPLIER TO CHANGE INTERMITTENT CATHETERS. PATIENT ADVISED THE PACKETS DID NOT BREAK, THEY HAD TO REMOVE THEM FROM THE PACKAGE AND CUT THEM WITH SCISSORS-CAUSING WATER TO BURST OVER THEIR FLOOR PATIENT WANTS THE MAGIC3 HOW TO GUIDE MAILED TO THEM AS A REFERENCE. FORWARD COPY OF CASE TO PRODUCT COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343303 ↗
• MalfunctionJan 21, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE CUSTOMER USED THE MAGIC 3 GO MALE INTERMITTENT CATHETER, THAT THE BLUE STICK TAB ON THE TOP OF THE CATHETER PACKAGING WAS MISSING FROM TWO BOXES OF THEIR CATHETERS. THE CUSTOMER REPORTED ISSUES WITH NO TABS WITH LOT# JUJT1285, LOT# JUJT1029. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14JAN2025, IT WAS REPORTED THAT THE CUSTOMER WAS INCONVENIENCED BY THE DEFECTIVE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196852 ↗
• MalfunctionDec 20, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE LEAKING. PER CUSTOMER FOLLOW UP RECEIVED ON 03DEC2024, IT WAS REPORTED THAT THEY THOUGHT CARDINAL MISREPORTED THIS INCIDENT - THE ISSUE WAS THAT THE ADHESIVE TAB ON THE PACKAGING WAS MISSING, AND THE PATIENT RELIES ON THAT PACKAGING FOR USE. AFTER DISCUSSING THE ISSUE WITH THEIR REPRESENTATIVE, THEY FOUND THAT THERE WAS A BRIEF PERIOD OF TIME WHERE THE ADHESIVE TAB WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986400 ↗
• MalfunctionNov 14, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE INTERMITTENT CATHETER DUE TO THE ADHESIVE MISSING. THEY WERE ABLE TO GET REPLACEMENT PRODUCT SENT, HOWEVER THE REPLACEMENT PRODUCT ALSO WAS MISSING THE ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683371 ↗
• MalfunctionSep 24, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT SOME INTERMITTENT CATHETERS ON PREVIOUS ORDER WERE TOO DRY. THIS CAUSED DISCOMFORT AND SOME BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 20292950 ↗
• MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEW INTERMITTENT CATHETERS ON LAST ORDER WERE TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256077 ↗
• MalfunctionSep 10, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS ARE TOO DRY. PATIENT NEEDED SOMETHING WITH A LITTLE MORE LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179558 ↗
• MalfunctionAug 28, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT HAVE A HOLE AT THE END OF IT. THERE WAS NO PATIENT HARM. ALSO, CUSTOMER HAD NINE OTHER CATHETERS THAT WERE DRY, NOT SURE IF THEY WERE FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087204 ↗
• MalfunctionAug 28, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT HAVE A HOLE AT THE END OF IT. NO PATIENT HARM. ALSO, CUSTOMER HAD NINE OTHER CATHETERS THAT WERE DRY, NOT SURE IF THEY WERE FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085240 ↗
• MalfunctionJul 2, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER DID NOT RECEIVE ORANGE SEAL OR BAND TO APPLY MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETER WITH LUBRICANT ALL 600 CATHETERS WERE MISSING LUBRICANT SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654804 ↗
• MalfunctionMay 28, 2024Improper Chemical Reaction; Component Misassembled; Improper Chemical Reaction; Component Misassembled

  IT WAS REPORTED THAT SOME BOXES HAD DEFECTIVE INTERMITTENT CATHETERS AND LUBRICATION OF THE CATHETERS WERE EMPTY OR TOTALLY DRIED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404624 ↗
• MalfunctionMay 24, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES IN A PMCF STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY CATHETERIZE THE PATIENT ON THE FIRST ATTEMPT, BECAUSE THERE WAS NO URINE DRAINING IN RELATION TO 53616G MALE INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393288 ↗