Espocan® 333165Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964179181), received between Apr 20, 2017 and May 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAVE BEEN HAVING ISSUES WITH FREQUENT INTRAVASCULAR CATHETERS WITH BOTH THE CSE AND EPIDURAL KITS. THE CATHETER SEEMS TO BE "MORE STIFF" IF THAT MAKES SENSE. THE OTHER ISSUE WITH THE KITS, IS THAT THE GLASS LOR SYRINGES ARE "STICKING." WE WET THEM WITH THE SALINE MULTIPLE TIMES, BUT THE SYRINGES STICK AND DO NOT GLIDE SMOOTHLY. AS FAR AS PTS BEING AFFECTED, THE INTRAVASCULAR CATHETERS HAVE NOT HAD AN ADVERSE EFFECTS FOR THE PATIENTS, BUT HAVE RESULTED IN LONGER PLACEMENT TIMES ALONG WITH MULTIPLE PLACEMENT ATTEMPTS. THE LOR SYRINGE ISSUE DID RESULT ON ONE WET TAP DURING PLACEMENT. THIS DID REQUIRE A BLOOD PATCH.

  Patient problems: Headache; Needle Stick/Puncture

  MAUDE report 14285558 ↗
• MalfunctionMay 3, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAVE BEEN HAVING ISSUES WITH FREQUENT INTRAVASCULAR CATHETERS WITH BOTH THE CSE AND EPIDURAL KITS. THE CATHETER SEEMS TO BE "MORE STIFF" IF THAT MAKES SENSE. THE OTHER ISSUE WITH THE KITS, IS THAT THE GLASS LOR SYRINGES ARE "STICKING." WE WET THEM WITH THE SALINE MULTIPLE TIMES, BUT THE SYRINGES STICK AND DO NOT GLIDE SMOOTHLY. THE INTRAVASCULAR CATHETERS HAVE NOT HAD AN ADVERSE EFFECTS FOR THE PATIENTS, BUT HAVE RESULTED IN LONGER PLACEMENT TIMES ALONG WITH MULTIPLE PLACEMENT ATTEMPTS. THE LOR SYRINGE ISSUE DID RESULT ON ONE WET TAP DURING PLACEMENT. THIS DID REQUIRE A BLOOD PATCH.

  Patient problems: Headache; Needle Stick/Puncture

  MAUDE report 14270129 ↗
• MalfunctionApr 20, 2017Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, WHILE WITHDRAWING EPIDURAL NEEDLE IT MET RESISTANCE AND TURNED A 1/8 TURN TO OVERCOME. AFTER NEEDLE REMOVED CATHETER MEASURED 40 AT SKIN LEVEL STARTED TO PULL IT BACK TO 30 MARK AND CATHETER SHEARED AT 37 MARK. A NEW SPINAL WAS PLACED BY ANESTHIOLOGIST AND SURGERY COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6507073 ↗