NA 219415Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705006403), received between May 1, 2019 and May 26, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Break; Degraded

  IT WAS REPORTED THAT THE TUNNEL DILATOR 12 MM-5 TO 120 MM HAD RUST. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE SHOWED SIGNS OF WEAR, TRACES OF FOREIGN MATTER AND MARKS OF STERILIZATION AROUND THE CANNULA. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279306 ↗
• MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 5 OF 8 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TUNNEL DILATOR, 12.0 MM DEVICE WAS CONTAMINATED UPON INSPECTION WITH A BORESCOPE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129148 ↗
• MalfunctionMar 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 5 OF 11 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 12.0 MM DEVICE HAD CONTAMINATION IN AND ALONG ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566530 ↗
• MalfunctionFeb 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 2 OF 28 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 12.0 MM DEVICE HAD CONTAMINATION INSIDE ITS CANNULATED SECTION. ACCORDING TO THE REPORT, THE EVENT OCCURRED BEFORE PROCESSING WHEN THE CUSTOMER DECIDED TO INSPECT THE DEVICE WITH THEIR BORESCOPE. IT WAS REPORTED THAT THE DEVICE WAS PURCHASED ON JUNE 2022; AND HAS NEVER BEEN USED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SHELVED AND STORED IN CONTROLLED ENVIRONMENT IN THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382129 ↗
• MalfunctionJan 23, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THAT DURING CONTROL IN THE WAREHOUSE, A TOTAL OF EIGHT (8) TUNNEL DILATOR (7.5 MM, 9.5 MM, 12.0 MM, 10.5 MM, 6.5 MM, 11.5 MM, 8.5 MM, 6.0 MM) PRESENTED RESIDUE IN THE CAVITY. THE DEVICES WERE NEW. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624584 ↗
• MalfunctionMay 1, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE IS A QUALITY PROBLEM OF EQUIPMENT NUMBER 500034163, TUNNEL DILATORS SIZES 6MM-10.5MM. THEY PRESENT THE ELIMINATION OF OXIDE AFTER STERILIZATION. THE PRODUCTS ARE CONSIGNED IN THE CLIENT. THIS COMPLAINT INVOLVES THIRTEEN DEVICES. THIS (B)(4) CAPTURES THREE DEVICES WHILE THE LINKED (B)(4) CAPTURES REMAINING TEN DEVICES. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570142 ↗