Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53514GRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741069710), received between Apr 26, 2017 and Mar 25, 2021 — classified as 7 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (16 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT DIFFICULTY IN INSERTING THE MAGIC3 HYDROPHILIC MALE INTERMITTENT CATHETERS WITH BLEEDING AND TOO MUCH FRICTION. SOME OF THE CATHETERS WERE NOT LUBRICATING PROPERLY, SO PATIENT HAD TO WITHDRAW THEM TO AVOID HURTING AND CAUSE BLEEDING. UPON EXAMINATION SOME CATHETERS WERE NOTICEABLY LARGER THAN THE OTHER CATHETERS. LIBERATOR REPLACED AND PATIENT HAD FOUND SAME ISSUE WITH THE MOST RECENT ORDER OF FEBRUARY 12. ALSO, SOME CATHETERS DID WORK AS THEY ALWAYS HAD, BUT MANY HAD TO BE WITHDRAWN AND TRY TO FIND ANOTHER THAT WILL WORK, INCREASING THE RISK OF INFECTION. THE HOME CARE NURSE CHECKED TO SEE IF THE PROBLEM WAS BECAUSE OF PATIENT'S PROSTRATE OR STRICTURES BUT FOUND NO EVIDENCE THAT IT WAS THE PRODUCT. ALSO, PATIENT'S UROLOGIST THOUGHT THAT PERHAPS THE PROBLEM AROSE SOMEHOW FROM STORAGE BEFORE RECEIVED THEM. NO MEDICAL INTERVENTION WAS REPORTED. AS PER THE FOLLOW UP ON 16MAR21, THERE WAS A NOTICEABLE DIFFERENCE IN THE DIAMETER OF SOME WHICH USER HAD TO WITHDRAW. HOWEVER, IT SEEMS THE LUBRICITY HAS BEEN THE BIG ISSUE (JUEV2250), EVEN WHEN USER USED AN ADDITIONAL SURGICAL LUBRICANT, AS ADVISED BY A HOME CARE NURSE. THE NURSE ALSO CHECKED

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

  MAUDE report 11569508 ↗
• MalfunctionOct 15, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACK LUBRICITY CAUSING PAIN AND DISCOMFORT TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; Pain

  MAUDE report 9191011 ↗
• MalfunctionOct 15, 2019Product Quality Problem; Device Slipped; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY ALLEGEDLY CAUSING PAIN AND DISCOMFORT TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; Pain

  MAUDE report 9191004 ↗
• MalfunctionOct 15, 2019Product Quality Problem; Defective Device; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACK LUBRICITY CAUSING PAIN AND DISCOMFORT TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; Pain

  MAUDE report 9191003 ↗
• MalfunctionAug 21, 2019Difficult to Insert

  IT WAS REPORTED THAT PATIENT HAD DIFFICULTY INSERTING THE CATHETER AND EXPERIENCED SELF-LIMITED BLEEDING. PATIENT WAS UNABLE TO VOID. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8916568 ↗
• MalfunctionJun 24, 2019Product Quality Problem; Product Quality Problem; Therapeutic or Diagnostic Output Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS TOO MUCH LUBRICANT ON THE MAGIC 3 CATHETER WHICH ALLEGEDLY MADE IT STICKY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8726586 ↗
• MalfunctionJun 12, 2019Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS "NOT VERY SLIPPERY " WHICH ALLEGEDLY MADE IT DIFFICULT TO INSERT. THE PATIENT WAS REPORTEDLY STILL ABLE TO VOID USING THE CATHETER BUT NOTED THAT IT SOMETIMES TAKES MINUTES TO GET THE CATHETER INSERTED. THE PATIENT REPORTEDLY EXPERIENCED PAIN WITH THE INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 8691916 ↗
• MalfunctionMay 16, 2019Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS WERE DIFFICULT TO INSERT RESULTING IN PAIN. THE PATIENT WAS NOT ABLE TO FULLY INSERT THE CATHETER FOR USE.

  Patient problems: Pain

  MAUDE report 8615833 ↗
• MalfunctionMay 13, 2019Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE CATHETERS WERE BENT INSIDE OF THE PACKAGING DEEMING THEM UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8604742 ↗
• MalfunctionApr 3, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE DIAMETER OF THE MAGIC 3 CATHETERS VARIED WITH SOME BEING WIDER THAN THEY SHOULD BE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8479112 ↗
• MalfunctionApr 2, 2019Product Quality Problem; Therapeutic or Diagnostic Output Failure; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DID NOT APPEAR TO HAVE A STANDARD AMOUNT OF LUBRICATION AS SOME WERE NOT LUBRICATED ENOUGH.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8475045 ↗
• MalfunctionMar 13, 2019Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS NOT LUBRICATED ENOUGH. AS A RESULT, THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT WHEN REMOVING THE CATHETER, HOWEVER WAS ABLE TO VOID.

  Patient problems: Discomfort

  MAUDE report 8418273 ↗
• InjuryFeb 6, 2019Difficult to Insert; Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS TOO FLIMSY AND COULD NOT BE INSERTED. THE PATIENT REPORTEDLY DEVELOPED A KIDNEY INFECTION FROM NOT BEING ABLE TO USE THE CATHETERS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH CIPRO.

  Patient problems: Unspecified Infection

  MAUDE report 8312290 ↗
• MalfunctionOct 31, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS WERE DIFFERENT SIZES. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025522 ↗
• MalfunctionOct 31, 2018Misassembled; Misassembled

  IT WAS REPORTED THAT THE YELLOW LINES ON THE CATHETERS WERE SHORTER THAN USUAL, THEREFORE MAKING THE CATHETER INSERTION AND VOIDING UNCOMFORTABLE. THE PATIENT ALLEGED HAVING A UTI (URINARY TRACT INFECTION), DUE TO THE SHORTER YELLOW GUIDELINES. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; Urinary Tract Infection

  MAUDE report 8025516 ↗
• MalfunctionOct 9, 2018Device Damaged Prior to Use; Sharp Edges; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETER WAS SHARP. THE PATIENT ALLEGEDLY CUT HIMSELF DURING USE AND EXPERIENCED SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 7947757 ↗
• MalfunctionOct 8, 2018Incorrect Measurement; Material Deformation; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE SMALLER THAN USUAL. THE COMPLAINANT REPORTED THAT THE CATHETERS WERE TOO SLIM, CAUSING THEM TO FOLD UP AND PREVENTED THE PATIENT FROM USING THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7943453 ↗
• InjurySep 20, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR A URINARY TRACT INFECTION AFTER USING THE MAGIC 3 CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 7894830 ↗
• MalfunctionSep 6, 2018Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SEAM ON THE SIDE OF THE MAGIC 3 CATHETER PACKAGE ABOUT THREE INCHES LONG.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7852311 ↗
• MalfunctionSep 6, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER REPLACEMENTS RECEIVED FROM BARD MEDICAL WERE BENT IN THE FEDEX BOX.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7850712 ↗
• MalfunctionSep 5, 2018Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER PACKAGING WAS NOT SEALED. ALLEGEDLY, THERE WAS AN OPEN SLIT ALONG THE SEAM OF THE PACKAGE. THE COMPLAINANT STATED THAT THE CATHETERS WERE NOT EXPOSED TO ANY HIGH TEMPERATURES OF 100F OR ABOVE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7847547 ↗
• MalfunctionAug 29, 2018Product Quality Problem; Appropriate Device Problem Term/Code Not Available; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7828884 ↗
• MalfunctionAug 27, 2018Product Quality Problem; Appropriate Device Problem Term/Code Not Available; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY. THE PATIENT ALLEGEDLY DEVELOPED IRRITATION; NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Irritation

  MAUDE report 7819584 ↗
• MalfunctionAug 22, 2018Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE PATIENT PULLED THE CATHETER FROM HIS BACKPACK, HE FOUND A SLIT IN THE PACKAGING APPROXIMATELY TWO INCHES LONG. HE ALSO NOTED THAT THE CATHETERS WERE NOT EXPOSED TO ANY HIGH TEMPERATURES OF 100F OR ABOVE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7807296 ↗
• MalfunctionAug 22, 2018Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE PATIENT PULLED THE CATHETER FROM HIS BACKPACK, HE FOUND A SLIT IN THE PACKAGING APPROXIMATELY ONE INCH LONG. HE ALSO NOTED THAT THE CATHETERS WERE NOT EXPOSED TO ANY HIGH TEMPERATURES OF 100F OR ABOVE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7807280 ↗