Single Use Guide Sheath Kit K-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170245480), received between Oct 5, 2023 and Feb 20, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Recalls naming this device

1. Jan 15, 2025Open, Classified

   Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

   Z-1071-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE FOR SUSPECTED PERIPHERAL LUNG CANCER, THE ULTRASONIC PROBE WAS USED IN COMBINATION WITH THE SINGLE-USE GUIDE SHEATH. UPON REMOVAL FROM THE PATIENT, IT WAS OBSERVED THAT APPROXIMATELY 5CM OF THE PROBE'S COATING HAD PEELED OFF. CT AND FLUOROSCOPY WERE IMMEDIATELY PERFORMED TO CHECK FOR RETAINED FRAGMENTS, AND NONE WERE DETECTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S CONDITION SUDDENLY DETERIORATED, REQUIRING EMERGENCY INTERVENTION. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WHERE DEATH WAS CONFIRMED THE SAME DAY. THE CAUSE OF DEATH WAS DOCUMENTED AS UNKNOWN, AND NO ADDITIONAL INFORMATION REGARDING AUTOPSY FINDINGS OR CONTRIBUTING FACTORS WAS AVAILABLE. THERE WERE NO REPORTS OF PROCEDURAL COMPLICATIONS, IMMEDIATE POST-PROCEDURAL ADVERSE EVENTS, OR CONFIRMED DEVICE-RELATED INJURY. THERE WAS NO REPORTED MALFUNCTION OR ISSUE WITH THE SINGLE-USE GUIDE SHEATH.

  Patient problems: Insufficient Information

  MAUDE report 21426812 ↗
• InjuryApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE RADIOPAQUE TIP OF SINGLE USE GUIDE SHEATH WAS LEFT IN THE PATIENT'S BRONCHUS DURING A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DEVICE RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19152531 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "COMPUTED TOMOGRAPHY BRONCHUS SIGN SUBCLASSIFICATION DURING RADIAL ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL BIOPSY: A RETROSPECTIVE ANALYSIS." THIS WAS A RETROSPECTIVE STUDY OF CONSECUTIVE PATIENTS WHO UNDERWENT RADIAL ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL BIOPSY (REBUS-TBB) FOR PERIPHERAL PULMONARY LESIONS BETWEEN NOVEMBER 2015 AND OCTOBER 2017. PATIENTS WITH CENTRAL PULMONARY LESIONS (PPLS) WITH EVIDENCE OF ENDOBRONCHIAL INVOLVEMENT, THOSE WHO UNDERWENT RE-EXAMINATION FOR THE SAME LESION, THOSE WITH UNKNOWN FINAL DIAGNOSIS DUE TO LOSS AT FOLLOW-UP, AND THOSE WITH LACK OF EVALUATION BY HIGH RESOLUTION CT (HRCT) IMAGING OF LESIONS THAT WERE LESS THAN 1MM IN THICKNESS WERE EXCLUDED. THE STUDY CONCLUDES THAT CT BRONCHUS SIGN SUBCLASSIFICATION MAY PROVIDE USEFUL INFORMATION TO FACILITATE THE SELECTION OF BRONCHOSCOPIC TECHNIQUES FOR ACCURATE DIAGNOSIS OF PPLS. REBUS-TBB GENERALLY HAD AN ACCEPTABLE DIAGNOSTIC PERFORMANCE IN CT-BS GROUP I. HOWEVER, TYPE IC IS EXCEPTIONAL, AND IT MAY BE USEFUL TO OBTAIN LARGER SAMPLES WITH A 1.9 MM FORCEPS (OR CONSIDER CRYOPROBES). REBUS-TBB IS NOT EXPECTED TO PROVIDE SUFFICIENT DIAGNOSTIC PERFORMANCE IN CT-BS

  Patient problems: Pneumothorax; Respiratory Tract Infection

  MAUDE report 18822565 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLOSE-TO-LESION TRANSBRONCHIAL BIOPSY: A NOVEL TECHNIQUE TO IMPROVE SUITABILITY OF SPECIMENS FOR GENETIC TESTING IN PATIENTS WITH PERIPHERAL PULMONARY LESIONS". LITERATURE SUMMARY: BRONCHOSCOPY WITH RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND, A GUIDE SHEATH, AND ELECTROMAGNETIC NAVIGATION CAN IMPROVE THE DIAGNOSTIC YIELD OF PERIPHERAL LUNG NODULES. HOWEVER, THE SUITABILITY OF SPECIMENS FOR GENETIC ANALYSIS REMAINS UNSATISFACTORY. WE HYPOTHESIZED THAT A TRANSBRONCHIAL BIOPSY PERFORMED AFTER CLOSELY APPROACHING THE BRONCHOSCOPE TIP TO THE LESION MIGHT PROVIDE MORE SUITABLE SPECIMENS FOR GENETIC ANALYSIS. WE ENROLLED 155 PATIENTS WITH PERIPHERAL PULMONARY LESIONS WHO UNDERWENT BRONCHOSCOPY WITH A THIN OR ULTRATHIN BRONCHOSCOPE. BRONCHOSCOPY WAS PERFORMED USING VIRTUAL BRONCHOSCOPIC NAVIGATION AND RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND WITH A GUIDE SHEATH. THE BRONCHOSCOPE TIP WAS PLACED CLOSER TO THE LESION DURING BRONCHOSCOPY TO COLLECT LARGER SPECIMENS WITH HIGHER MALIGNANT CELL CONTENT. THE PATIENTS WHO UNDERWENT A CLOSE-TO-LESION BIOPSY HAD HIGHER RATES OF OVERALL DIAGNOSTIC YIELD, HISTOPATHOLOGICAL DIAGNOSTIC YIELD, AND

  Patient problems: Decreased Appetite; Low Oxygen Saturation; Pneumonia

  MAUDE report 17878730 ↗