SureStep Intermittent Catheter Tray INTP16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741183300), received between Jun 7, 2022 and Jan 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 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. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3117-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJan 30, 2026Component Misassembled

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER HAD NO OPEN HOLE AT THE END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228793 ↗
• MalfunctionDec 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE LAST SEVERAL INTERMITTENT KITS CUSTOMER USED HAS BEEN THIS WAY. THE INTERMITTENT CATHETER WAS LOOPED OUTSIDE OF THE WRAPPER, SO IT WAS VERY DIFFICULT TO OPEN AND MAINTAIN STERILITY. HAD TO GET A NEW TRAY FOR STERILITY OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300133 ↗
• MalfunctionMay 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT TWO BARD INTERMITTENT CATHETER KITS FROM DIFFERENT LOTS (NGHN0240, NGGY1050) WHEN OPENED, HAD THE CATHETER STICKING OUT OF STERILE WRAP WHEN THE FIRST FLAP WAS UNFOLDED. UPON REVIEW OF THE MEDWATCH FORM PROVIDED BY (B)(6) ON (B)(6) 2023, THIS WAS MERELY A REPORTED EVENT AND NOT A COMPLAINT AGAINST THE SURESTEP INTERMITTENT TRAY. THE CUSTOMER HAD MADE IT CLEAR THAT THERE WERE NO SAMPLES AVAILABLE TO RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031782 ↗
• MalfunctionMay 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT TWO BARD INTERMITTENT CATHETER KITS FROM DIFFERENT LOTS (NGHN0240, NGGY1050) WHEN OPENED, HAD THE CATHETER STICKING OUT OF STERILE WRAP WHEN THE FIRST FLAP WAS UNFOLDED. UPON REVIEW OF THE MEDWATCH FORM PROVIDED BY (B)(6) ON (B)(6) 2023, THIS WAS MERELY A REPORTED EVENT AND NOT A COMPLAINT AGAINST THE SURESTEP INTERMITTENT TRAY. THE CUSTOMER HAD MADE IT CLEAR THAT THERE WERE NO SAMPLES AVAILABLE TO RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031556 ↗
• MalfunctionJun 7, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS NOT FIRMLY ATTACHED TO THE BAG AND CAME APART VERY EASILY. STATED THAT IT CAME APART DURING ONE TIME WHILE CATHETERIZING THE PATIENT AND TRIED TO LOWER THE BAG SO THEY COULD SEE IF IT HAD STOPPED DRAINING. THEY PREDICTED THAT THEIR STAFF WOULD JUST DISCONNECT THE BAG FROM THE CATHETER AND LET THE URINE DRAIN INTO THE TRAY PROVIDED, COMPLETELY NEGATING THE GOAL OF A CLOSED SYSTEM. ALSO STATED THAT THEY PERSONALLY TRIED THE CATHETER THREE DIFFERENT TIMES, THE 14 FR TWICE AND THE 16 FR ONCE. THEY DID NOT NOTICE A FASTER FLOW IN EITHER BUT DID LIKE THE FIRMNESS OF THE CATHETER AND FELT IT INSERTED AROUND THE INFANT'S HEAD EASIER. BUT SADLY THEY DID HAVE THE CATHETER DISCONNECT FROM THE BAG VERY EASILY WHILE TRYING TO GET IT TO FLOW BETTER AND AS SUSPECTED, URINE ALL OVER THE BED. THERE WERE 10 CATHETERS AFFECTED FROM EACH TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622174 ↗