HydroSil Go™ Intermittent Urinary Catheter 71812Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741097997), received between Jul 17, 2017 and Mar 12, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE USER HAD TROUBLE WITH INSERTING ONE OF THE INTERMITTENT CATHETERS THIS MONTH BECAUSE IT WAS VERY FLIMSY AND WOULD NOT INSERT. PATIENT ALSO STATED THAT THEY TRIED TO INSERT ONE YESTERDAY INSTEAD AS HAD STRUGGLES WITH THE FIRST ONE AND THE LIQUID THEY INSERTED WITH THE CATHETER STARTED COMING OUT WHICH HAD NOT HAPPENED BEFORE. PER ADDITIONAL INFORMATION VIA EMAIL FROM (B)(4) ON (B)(6) 2024, IT WAS STATED THAT THERE WAS NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885438 ↗
• MalfunctionOct 15, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PATIENT ADVISED HALF A BOX OUT OF PREVIOUS DELIVERY SEEMED LIKE IT HAD BEEN CRUSHED IN TRANSITION. ALSO STATED THAT CATHETERS WERE OPENED AND DRIED SO UNABLE TO USE. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 28SEP2021, PATIENT WAS NOT ABLE TO USE THE DEVICE AS THEY WERE DAMAGED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 13OCT2021, THE CUSTOMER RECEIVED THE CATHETERS ALREADY OPENED AND DRIED. UNCERTAIN IF THEY OPENED DURING TRANSIT OR BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639886 ↗
• MalfunctionMar 2, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ONE OF THE BOXES HAD ABOUT 8 HYDROSIL INTERMITTENT CATHETERS THAT WERE NOT STRAIGHT AND THEY WERE BENT. THE PATIENT USED ONE OF THE CATHETER AND IT CAUSED THE PAIN. THE PATIENT DID WITH THE OTHER ONES THAT WERE BENT. PER FOLLOW UP WITH THE IBC VIA EMAIL ON 01FEB2021 THERE WAS NO PHOTO SAMPLE AVAILABLE. THE PATIENT COULD NOT USE AND THEREFORE NO PAIN CONTROL NEEDED.

  Patient problems: Pain

  MAUDE report 11398322 ↗
• MalfunctionJul 29, 2020Partial Blockage; No Flow; Partial Blockage

  IT WAS REPORTED THAT SOME CATHETERS WERE FAULTY. THE PATIENT FOUND THAT THE CATHETER WOULD NOT DRAIN THE URINE AND WHEN LOOKED AT THE CATHETER CLOSER, THE HOLE SEEMS TO BE BLOCKED. THE PATIENT WAS UNSURE WHETHER IT WAS CLOGGED WITH THE GEL..

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

  MAUDE report 10339301 ↗
• MalfunctionMay 23, 2018Kinked; Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETERS WERE KINKED. THE USER STATED THAT ONE BOX OF 15 HAD KINKS IN THEM AND COULD NOT BE USED. ANOTHER BOX OF 22 ALSO HAD KINKS. THE PATIENT STATED THAT SHE DID NOT USE THE CATHETERS ONCE THE PACKET WAS OPENED.

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

  MAUDE report 7536494 ↗
• MalfunctionMay 1, 2018Deformation Due to Compressive Stress; Kinked; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETERS WERE KINKED. SOME OF THE CATHETERS WERE ALSO FLIMSY AND HARD TO MANEUVER. INSTEAD OF GOING IN THE BLADDER THEY WOULD GO INTO THE WOMB. THE USER STATED THAT ONE BOX CONTAINED 15 KINKED CATHETERS AND COULD NOT BE USED. ANOTHER BOX CONTAINED 22 KINKED CATHETERS. SHE STATED THAT THIS ADDED STRESS TO THE SITUATION AND SHE COULD NOT RELAX ON HER HOLIDAY AND SHE FEELS IT WAS A WASTE OF MONEY AND PRODUCTS.

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

  MAUDE report 7478539 ↗
• MalfunctionDec 14, 2017Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE NOT LUBRICATED AND WERE UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7116954 ↗
• MalfunctionAug 24, 2017Material Too Rigid or Stiff; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETERS WERE NOT SMOOTH. THE NURSE USED THEM WITH A PATIENT, TO TEACH HIM INTERMITTENT CATHETERISATION. THE CATHETERS WERE ROUGH AND UNCOMFORTABLE FOR THE PATIENT. THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: Discomfort

  MAUDE report 6817777 ↗
• MalfunctionJul 17, 2017Component Missing; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICATION, AND A DEAD FLY WAS STUCK TO ANOTHER. IT WAS LATER REPORTED THAT THE CATHETERS WERE THROWN AWAY, AND THEY TRIED TO LUBRICATE THE DRY ONES THEMSELVES. THERE WAS NOTHING THAT COULD BE RETURNED.

  Patient problems: No Information

  MAUDE report 6718034 ↗