Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 52610GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741069697), received between Jul 5, 2018 and Nov 24, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER WAS REACHING OUT BECAUSE THEY HAVE NOTICED ONGOING ISSUES WITH THE CATHETERS THEY RECEIVED. THE SIZES HAVE BEEN INCONSISTENT FROM ONE CATHETER TO ANOTHER, EVEN THOUGH THEY WERE LABELED AS THE SAME SIZE. THIS INCONSISTENCY WAS CAUSING DISCOMFORT AND MAKING IT DIFFICULT TO USE THEM SAFELY AND PROPERLY. THEY WOULD APPRECIATE IT IF THEY COULD LOOK INTO THIS ISSUE AND ADVISE ON HOW IT COULD BE RESOLVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23639866 ↗
• MalfunctionJul 18, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DRAINED SLOWER THAN USUAL. THE CUSTOMER REPORTED THAT THE CATHETER SOMETIMES DRAINS NO URINE AT ALL. IT WAS ALSO NOTED THAT THE PATIENT INSERTS THE CATHETER VIA THE STOMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7700329 ↗
• MalfunctionJul 16, 2018Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE COMPLAINANT FELT THERE WAS NOT ENOUGH WATER WITHIN THE WATER PACKETS TO PROPERLY LUBRICATE THE CATHETER.

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

  MAUDE report 7690508 ↗
• InjuryJul 5, 2018Inaccurate Flow Rate; Improper Flow or Infusion; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER DID NOT COMPLETELY DRAIN. THE COMPLAINANT REPLACED THE CATHETER TO FULLY VOID THE PATIENT. IT WAS LATER REPORTED BY THE CUSTOMER CONTACT ON (B)(6) 2018, THAT THE CATHETER DID NOT DRAIN AND THE URINE SHOT BACK INTO THE PATIENT'S BLADDER. THE PATIENT ALLEGEDLY EXPERIENCED AN URINARY TRACT INFECTION AND WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7664154 ↗
• MalfunctionJul 5, 2018Misassembled; Obstruction of Flow; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES WERE CLOSED.

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

  MAUDE report 7664097 ↗