Magic3 Go Male Catheter with SureGrip 53810GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741136948), received between Jun 4, 2018 and Apr 3, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 20, 2023Class IIOpen, Classified

   Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

   Z-1699-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE ORDERS HAVE CONTAINED DIFFERENT SIZE MALE EXTERNAL CATHETERS BUT ARE MARKED AS 10FR. REPRESENTATIVE ADVISED THAT WHEN THIS OCCURS PATIENT NEEDS TO LET US KNOW SO WE CAN RESOLVE THAT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663482 ↗
• MalfunctionJan 14, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT UPON OPENING THE MAGIC 3 GO MALE INTERMITTENT CATHETER OUT OF THE PACKAGE, THE PATIENT WAS NOT ABLE TO USE THE CATHETER DUE TO STEM DISFIGUREMENT. THE COMPLAINANT STATED THAT THEY WERE NOT SURE BUT BELIEVED THE PATIENT MIGHT HAVE STILL TRIED TO USE THE CATHETERS AND THAT IT HURT, BUT THE COMPLAINANT COULD NOT FULLY CONFIRM IF THAT WAS THE CASE OR IF THE PATIENT JUST DECIDED TO NOT USE IT AT ALL. THE PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS. IT WAS MENTIONED AS OUT OF BOX FAILURE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258339 ↗
• InjurySep 22, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE INTERMITTENT CATHETER WAS TOO SMALL, AND IT WAS NOT WORKING WELL FOR THE PATIENT. IT WAS STATED THAT THE PATIENT ORDERED FOR #2856627, BUT THE SAMPLE SENT IN ORDER WAS #2868610 WHICH WAS TOO SMALL. THE PATIENT AFFECTED WITH DEMENTIA. THE PATIENT WOULD PREFER BAR53812G, WHICH WAS BACKORDERED. THE PATIENT COULD NOT HOLD ON TO THEM, WHICH MEANS THEY HOLD THEIR URINE. THE PATIENT NEEDED SOME MORE TIME TO DECIDE WHETHER THE CATHETERS WERE WORKING, SINCE THE PATIENT HAD DEMENTIA. PER CUSTOMER VIA PHONE ON (B)(6) 2022, CUSTOMER STATED THAT THEY DID CONTRACT A VERY BAD URINARY TRACT INFECTION AND HAD TO GO TO THE HOSPITAL, HOWEVER, THEY BELIEVED IT WAS DUE TO THE CIRCUMSTANCES OF HAVING TO SWITCH CATHETER TYPES SO OFTEN DUE TO SUPPLY SHORTAGES AND NOT AN ACTUAL DEFECT WITH THE PRODUCTS. STATED THAT THE PATIENT WAS GIVEN AN ANTIBIOTIC FOR THE URINARY TRACT INFECTION BUT THEY DID NOT KNOW THE NAME OF IT. THE PATIENT WAS DOING FINE NOW.

  Patient problems: Dementia; Urinary Tract Infection

  MAUDE report 12513435 ↗
• MalfunctionJul 7, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE CATHETERS DID NOT HAVE ENOUGH LUBRICANT ON THEM AND THE PATIENT EXPERIENCED IRRITATION. ALSO STATED THAT THE PATIENT HAD LUBRICANT TUBE BUT THERE WAS NOT ENOUGH ROOM TO PUT THE LUBRICANT ON AND THE PATIENT WANTED TO TRY THE PACKETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129038 ↗
• MalfunctionAug 6, 2020Incorrect Measurement; Inadequacy of Device Shape and/or Size; Device Displays Incorrect Message; Incorrect Measurement

  IT WAS REPORTED THAT ONE OF THE SAMPLES WERE DEFECTIVE AND THE DIAMETER WAS TOO SMALL.

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

  MAUDE report 10376063 ↗
• MalfunctionJun 9, 2020Collapse; Collapse; Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS HAD AN INDENTATION ON END OF THE CATHETER AND WAS DIFFICULT TO INJECT THE SYRINGE TO FLUSH THE BLADDER.

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

  MAUDE report 10133650 ↗
• MalfunctionNov 6, 2019Misassembled; Defective Device; Misassembled

  IT WAS REPORTED THAT THE DISTRIBUTOR INFORMED US DURING A DEMO THEY NOTED THE PRODUCT HAD NO HOLES. IT WAS NOTED IN 4 UNITS WITH THE SAME CODE AND LOT NUMBER.

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

  MAUDE report 9286097 ↗
• MalfunctionOct 21, 2019Difficult to Insert; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE CATHETERS ALLEGEDLY CAUSED IRRITATION MAKING THEM DIFFICULT TO INSERT. THE PATIENT WAS UNABLE TO FULLY INSERT AND VOID USING THE DEVICE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9215301 ↗
• MalfunctionJun 4, 2018Product Quality Problem; Device Operates Differently Than Expected; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS WATER INSIDE THE CATHETERS, HOWEVER THE OUTSIDE OF THE CATHETERS WERE COMPLETELY DRY. THE PATIENT REPORTED HE HAD TO USE HIS OWN LUBRICANT TO LUBRICATE THE CATHETER.

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

  MAUDE report 7566017 ↗