NA 219406Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705006311), received between May 1, 2019 and May 28, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Degraded; Device Contaminated During Manufacture or Shipping; Degraded; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE NEWLY RECEIVED TUNNEL DILATOR 7.5MM DEVICE CONTAINED A SIGNIFICANT AMOUNT OF METAL SHAVINGS AND RUST INSIDE THE INNER CANNULA, AS CONFIRMED BY A BOROSCOPE EXAMINATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099716 ↗
• MalfunctionSep 9, 2024Degraded; Contamination /Decontamination Problem; Degraded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS FOUND THAT THE TUNNEL DILATOR 7.5MM DEVICE WAS CORRODING OR RUSTING ON THE CANNULATED ASPECT OF THE ITEM. IT WAS REPORTED THAT THE DEVICE HAD BEEN USED ONCE OR TWICE. ATTEMPTS TO CLEAN THE DEVICE FOUND SMALL DARK RED FLAKES WERE SEEN EXITING THE CANNULATION OF THE ITEM AS WELL AS LEAVING DARK RED STAINS ON THE PAPER TOWEL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT DEVICE HAD FOREIGN MATERIAL OBSERVED COULD BE RELATED TO HUMAN FLUID OR TISSUE. RESIDUES OF SALINE SOLUTION WAS OBSERVED, THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173121 ↗
• MalfunctionFeb 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM THE SALES REP ON AN UNSPECIFIED DATE THAT THE TUNNEL DILATOR 6.5MM *EA DEVICES (X6) DILATOR HAD CONTAMINANTS (RUST AND METAL SHAVINGS) IN THE CANNULATED SLEEVE OF THE INSTRUMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747702 ↗
• MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 4 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, 7.5 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 17129213 ↗
• MalfunctionMar 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 6 OF 11 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 7.5 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 16566499 ↗
• MalfunctionFeb 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 6 OF 28 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 7.5 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 (B)(6) 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 16382460 ↗
• 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 9624188 ↗
• 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 (B)(4), 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 TEN DEVICES WHILE THE LINKED (B)(4) CAPTURES REMAINING THREE DEVICES. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570020 ↗