Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53512GRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741069703), received between Jun 21, 2017 and Jul 10, 2019 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED AFTER INVESTIGATION OF A SAMPLE RECEIVED THAT THE CATHETER SAMPLES OUTER DIAMETER WAS MEASURED, AND WERE FOUND TO BE LOW OUT OF SPECIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777871 ↗
• MalfunctionJun 24, 2019Short Fill; Material Rupture; Short Fill; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE BURST PACKETS DID NOT HAVE ENOUGH SOLUTION TO LUBRICATE THE CATHETERS.

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

  MAUDE report 8727922 ↗
• MalfunctionMay 14, 2019Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE. THE PATIENT ADVISED THAT THE LAST TWO INCHES OF THE CATHETER TOOK A LOT OF PRESSURE TO REMOVE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 8608023 ↗
• MalfunctionFeb 26, 2019Nonstandard Device; Material Integrity Problem; Material Twisted/Bent; Nonstandard Device

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS THIN, AND CAUSED THE CATHETER TO BEND UPON INSERTION.

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

  MAUDE report 8371796 ↗
• MalfunctionJan 31, 2019Component Missing

  IT WAS REPORTED THAT THE WATER PACKET WAS MISSING FROM THE MAGIC 3 CATHETER PACKAGE.

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

  MAUDE report 8293492 ↗
• MalfunctionSep 17, 2018Incorrect Measurement; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE DIAMETER OF THE CATHETER SEEMED LARGER THAN USUAL. THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT DURING USE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Discomfort

  MAUDE report 7882549 ↗
• MalfunctionSep 6, 2018Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER DIAMETER WAS LARGER THAN 12FR, AT LEAST 14FR.

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

  MAUDE report 7852643 ↗
• MalfunctionAug 6, 2018Filling Problem; Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NO WATER IN THE BURST PACKET.

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

  MAUDE report 7754200 ↗
• MalfunctionJul 19, 2018Incorrect Measurement; Material Twisted/Bent; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS THICKER THAN USUAL.

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

  MAUDE report 7704128 ↗
• MalfunctionJul 18, 2018Device Damaged Prior to Use; Positioning Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE SURFACE OF THE MAGIC 3 CATHETER WAS ROUGH, WHICH ALLEGEDLY MADE THE CATHETER DIFFICULT TO INSERT AND IRRITATED THE URETHRA.

  Patient problems: Irritation

  MAUDE report 7698381 ↗
• MalfunctionJul 18, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DID NOT HAVE ENOUGH LUBRICATION.

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

  MAUDE report 7697966 ↗
• MalfunctionJul 5, 2018Incorrect Measurement; Use of Device Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS 14FR INSTEAD OF 12FR.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7664471 ↗
• InjuryJun 21, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION AFTER USE. ALLEGEDLY, THERE WAS BURNING AND PAIN DURING USE.

  Patient problems: Burning Sensation; Pain; Urinary Tract Infection

  MAUDE report 6658968 ↗