NA 219411Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705006366), received between May 1, 2019 and May 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break; Degraded

  IT WAS REPORTED THAT THE TUNNEL DILATOR 6.5MM DEVICE HAD RUST AND METAL SHAVINGS INSIDE, THE TUNNEL DILATOR 7.0MM DEVICE HAD RUST INSIDE, THE TUNNEL DILATOR 8.5MM DEVICE HAD RUST AND METAL SHAVINGS INSIDE, THE TUNNEL DILATOR 9.5MM DEVICE HAD RUST AND METAL SHAVINGS INSIDE, THE TUNNEL DILATOR 10.0MM DEVICE HAD RUST AND METAL SHAVINGS INSIDE, THE TUNNEL DILATOR 10.5MM DEVICE HAD RUST INSIDE, THE TUNNEL DILATOR 11.0MM DEVICE HAD RUST AND METAL SHAVINGS INSIDE, THE TUNNEL DILATOR 11.5MM DEVICE HAD RUST INSIDE, AND THE TUNNEL DILATOR 12.0MM DEVICE HAD RUST INSIDE. IT WAS NOT REPORTED IF THE DEVICES 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. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086788 ↗
• MalfunctionSep 10, 2024Degraded; Contamination /Decontamination Problem; Degraded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS FOUND THAT THE TUNNEL DILATOR 10.0MM 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. 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 20179458 ↗
• MalfunctionAug 21, 2024Break; Degraded; Break; Degraded

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING INSPECTION WITH A BOROSCOPE, IT WAS OBSERVED THAT THE TUNNEL DILATOR 10.0MM DEVICE HAD RUST AND METAL SHAVINGS IN THEM EVEN WITH BEING BRAND NEW. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010935 ↗
• MalfunctionAug 19, 2024Break; Degraded; Break; Degraded

  THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING INSPECTION WITH A BAROSCOPE, IT WAS OBSERVED THAT THE TUNNEL DILATOR 9.0MM DEVICE HAD RUST AND METAL SHAVINGS IN THEM EVEN WITH BEING BRAND NEW. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999587 ↗
• MalfunctionApr 25, 2024Degraded; Device Contaminated During Manufacture or Shipping; Degraded; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING INSPECTION WITH A BOROSCOPE, IT WAS OBSERVED THAT THE TUNNEL DILATOR 9.0MM DEVICE HAD RUST AND METAL SHAVINGS IN THEM EVEN WITH BEING BRAND NEW. THIS EVENT DID NOT OCCUR DURING SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186456 ↗
• 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 6 OF 6 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747976 ↗
• MalfunctionJun 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 6 OF 8 FOR (B)(6). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE TUNNEL DILATOR, 10.0 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 17129149 ↗
• MalfunctionMar 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 7 OF 11 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 10.0 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 16566491 ↗
• MalfunctionFeb 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 28 FOR (B)(4). IT WAS REPORTED BY THE FIELD SERVICE ENGINEER THAT DURING INSPECTION, THE CUSTOMER OBSERVED THAT THE TUNNEL DILATOR, 10.0 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 16382655 ↗
• 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 9 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569994 ↗