Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GRecalls & reported problems

Summary

The FDA's MAUDE database contains 692 adverse event reports that list this exact device (DI 00801741069772), received between Apr 26, 2017 and Apr 8, 2026 — classified as 93 injuries, 599 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (94 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 692 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Component Misassembled

  IT WAS REPORTED THAT THE PRODUCT HAD BEEN USED FOR YEARS. IN THE CURRENT LOT, THREE CATHETERS WERE FOUND WITHOUT EYELET HOLES. THREE OUT OF THIRTY WAS CONSIDERED A SIGNIFICANT AMOUNT. THIS WAS THE FIRST OCCURRENCE OF THIS ISSUE, AND THE CONCERN WAS REPORTED TO MAKE THE ISSUE KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816057 ↗
• MalfunctionApr 2, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER STATES THAT THE RH53614G ARE TOO BIG, HE NEEDS 12FR. PATIENT HAS ORDERED THIS PRODUCT PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766784 ↗
• MalfunctionMar 9, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE CATHETERS IN THE MANUFACTURER'S BOX WERE TWISTED AND BENT. NO ADDITIONAL INFORMATION PROVIDED. PATIENT HAS USED THIS PRODUCT BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553219 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THE BOX IS SMALL, SO THEY GET BENT SOMETIMES, 5 IN ONE BOX ARE BENT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951655 ↗
• MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent

  PATIENT SAID SOMETIMES GETS CATHETERS THAT HAVE NO OR VERY LITTLE WATER IN THE BURST PACK. HAS HAD A FEW THAT ARE TWISTED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857709 ↗
• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAS NOTICED A MORE SIGNIFICANT CURVE TO THE INTERMITTENT CATHETERS THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604469 ↗
• MalfunctionNov 13, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE FLATTENED AND HAD POINTY TIPS. THEY WERE UNCOMFORTABLE DURING INSERTION BUT DID NOT CAUSE INJURY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23545817 ↗
• MalfunctionNov 13, 2025Collapse; Collapse

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE FLATTENED AND HAD POINTY TIPS. THEY WERE UNCOMFORTABLE DURING INSERTION BUT DID NOT CAUSE INJURY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23545042 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT SAID THAT HE KEEPS GETTING UTI'S. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23199759 ↗
• MalfunctionSep 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THAT A FEW WERE 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 23123531 ↗
• InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TOO MANY URINARY TRACT INFECTIONS SO IS NO LONGER CATHETERIZING. IT IS UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 05NOV2025, IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR ONE WEEK AND WAS IN REHAB FOR 3 WEEKS AS A RESULT OF RECEIVING UTI'S AFTER USING THE REPORTED PRODUCT. CUSTOMER REPORTED PK2450012 AND 8/2019 AS THE INFORMATION DISPLAYED ON THE PACKAGING. SAMPLE IS AVAILABLE. PENDING SAMPLE RETURN. CUSTOMER STATED THAT HE COMPLETELY DISCONTINUED USE OF THE CATHETERS AFTER HIS HOSPITALIZATION WHICH CAUSED A FLARE UP WITH HIS MULTIPLE SCLEROSIS CONDITION.

  Patient problems: Urinary Tract Infection

  MAUDE report 23110202 ↗
• MalfunctionSep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT STATED CATHETERS ARE DEFECTIVE. THERE IS A SPLIT AT THE END THAT CONNECTS TO BAG, TIPS ARE MAULED, RUFF CUT. LOT# JUKQ9510. RETURNING 15 UNOPENED BOXES QTY 450. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938395 ↗
• MalfunctionAug 14, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT INTERMITTENT CATHETER INSIDE SLEEVE THE WATER PACKET WAS ALREADY RUPTURED. PER ADDITIONAL INFORMATION RECEIVED EMAIL ON 15AUG2025 STATED THAT THEY HAD USED AND ADDED EXTRA LUBRICANT AND IT WAS PAINFUL BUT THEY MADE IT WORK AND THEY HAD NO OTHER CHOICE. AND VERY DIFFICULT TO USE TWO BOXES BECAUSE ALL THE LUBRICANT WAS POPPED THE CATHETERS DRIED OUT AND BECAME ROUGH AND PAINFUL TO USE. ALSO MENTIONED TWO BOXES OF BARF CATHETERS THEY RECEIVED FROM EDGEPARK WERE BUSTED THE LIQUID INSIDE WAS ALREADY POPPED SEEMINGLY AND THE CATHETERS WERE NO LONGER ABLE TO BE LUBRICATED THAT WAY AND WERE DRY AND ROUGH AND CALLED EDGEPARK FOR ASSISTANCE BUT THEY SAID ONLY BARD COULD REPLACE THEM. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22803827 ↗
• MalfunctionAug 6, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PT HAD A DEFECTIVE CATHETER THAT DID NOT HAVE EYELETS AT ALL. 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 22726536 ↗
• MalfunctionJul 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A FEW OF THE INTERMITTENT CATHETERS WERE BENT TOO MUCH AND WERE NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500280 ↗
• MalfunctionJul 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID MULTIPLE BOXES IN THIS ORDER WERE NOT LUBRICATED AND DID NOT HAVE THE SURE GRIP SLIDER. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485417 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT KEPT GETTING URINARY TRACT INFECTIONS BUT DID NOT KNOW WHY. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22459238 ↗
• MalfunctionJul 9, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THE PATIENT SAID MULTIPLE BOXES IN THIS ORDER WERE NOT LUBRICATED AND DID NOT HAVE THE SURE GRIP SLIDER. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459201 ↗
• MalfunctionJul 9, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTER THE PATIENT STATED THAT CATHETER IS NOT FUNCTIONING. THAT THE END OF THE TIP HAS NO HOLES. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459180 ↗
• MalfunctionJul 2, 2025Defective Device; Defective Device

  PT STATED WITH EVERY ORDER THERE IS 2 OR 3 CATHETERS THAT ARE BENT UP AND UNUSABLE. PATIENT EMAIL ADDRESS: (B)(6). PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON30JUN2025, SORRY TO TAKE SO LONG TO RESPOND BUT IT'S DIFFICULT TO LIST EXACT DATES AND BATCHES OF PROBLEM CATHETERS. I DID NOT RECORD THE EXACT NUMBER AND TIMES I HAD A PROBLEM BUT THE PROBLEMS WERE MAINLY WITH A BATCHES FROM SEVERAL MONTHS AGO. CURRENTLY THE ISSUES HAVE NOT BEEN A PROBLEM. I HAVE BEEN USING THE CURRENT CATH TYPE SINCE 2019 AND HAVE BEEN SATISFIED WITH THE QUALITY UP TO THE MALFORMED ONES WHICH MANLY OCCURRED IN LATE 2024 AND EARLY 2025. I USE AN AVERAGE OF 5 PER DAY AND FOUND SEVERAL BOXES HAVING UP TO 3 MALFORMED CATH. I WILL RECORD ANY FUTURE DEFECTS AND ALSO RECORD THE BATCH ID'S IF THEY HAPPEN AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383971 ↗
• MalfunctionJul 2, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THE CUSTOMER STATED THEY WANT THE PACKAGE THAT THEY ARE ABLE TO STICK ON THE WALL. THE NEW PACKAGING DOESN'T HAVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383319 ↗
• MalfunctionJun 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE BENDING. LOT NUMBER WILL NOT BE AVAILABLE. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329078 ↗
• MalfunctionJun 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PT INDICATED ONE OF THE CATHETERS HE RECEIVED DID NOT HAVE ANY EYELETS. (NOTE: THIS COMPLAINT WAS RECEIVED VIA US MAIL. THE PT'S LETTER, WHICH ACCOMPANIED THE RETURN SAMPLE HE SENT TO LMS, WILL BE ATTACHED TO THE COMPLAINT FILE ONCE IT IS OPENED IN GCS/TW). PLEASE HAVE A BIOHAZARD BOX SENT TO: (B)(6). PER PATIENT COMPLAINT FORM RECEIVED ON 29MAY2025, JUST WANT TO MAKE YOU AWARE OF A PANIC SITUATION I HAD ON (B)(6) 2025. I HAVE USED YOUR CATHETERS FOR MORE THAN 7 YEARS, NEVER HAD A PROBLEM, NEVER HAD A COMPLAINT. ON SATURDAY ON (B)(6) 2025 AT 10:00PM, I BECAME PANIC STRICKLE WHEN I INSERTED A CATHETER BECAUSE I HAD AN URGE TO URINATE AND NOTHING CAME OUT. I PULLED THE CATHETER OUT AND REINSERTED IT AND ONCE AGAIN NOTHING CAME OUT. I'M IN A PANIC, WHERE IS THE URINE GOING. IS IT FLOWING THOUGHT MY BODY. WILL SEPSIS POISON MY BODY AND KILL ME. WHAT SHOUT I DO. SHOULD I ALL (B)(6), SHOULD I TRY TO DRIVE AN EMERGENCY HOSPITAL, WHICH ONE? I WAS PANICKY. I TOLD MYSELF SLOW DOWN THINK WHAT TO DO. I LOOKED AT THE CATHETER; I WIPED OFF THE EXIT END. PUT IT IN MY MOUTH AND BLEW. NOTHING THE ENTRANCE TIP WAS NOT OPEN. I PULLED OUT ANOTHER CATHETER INSERTED IT, URINE FL

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

  MAUDE report 22182955 ↗
• MalfunctionJun 4, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATED THAT THERE ARE VERY SHARP POINTS AT THE TIP OF THE CATHETERS THAT CAUSE BLEEDING WHEN INSERTING. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 22140772 ↗
• MalfunctionMay 16, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE EXTREMELY STICKY AND HAD A DIFFERENT CONSISTENCY COMPARED TO PREVIOUS ORDERS. THEY MENTIONED THAT THEY OPENED EACH CATHETER INDIVIDUALLY TO INSPECT THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036944 ↗