Subtle Cannula with Guide CSK-6130Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143900280), received between Oct 25, 2022 and Oct 25, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K120857, K142084); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 78-YEAR-OLD MALE PATIENT UNDERWENT A STAGED HYBRID THERAPY AND CONCOMITANT LEFT ATRIAL APPENDAGE EXCLUSION PROCEDURE. DURING THE MINIMALLY INVASIVE PROCEDURE, PHYSICIAN OBSERVED BLEEDING, THAT IN HIS MEDICAL OPINION, NECESSITATED CONVERSION OF ACCESS TO MEDIAN STERNOTOMY. CONVERSION TO STERNOTOMY WAS PERFORMED IN ORDER TO PRECLUDE POTENTIALLY LIFE-THREATENING INJURY. HOWEVER, UPON VISUALIZATION/EXAMINATION OF HEART AND SURROUNDING STRUCTURES THROUGH MEDIAN STERNOTOMY ACCESS, NO SOURCE FOR OBSERVED BLEEDING WAS IDENTIFIED, THUS NO FURTHER INTERVENTIONS WERE PERFORMED. THE ABLATION PROCEDURE WAS COMPLETED AS PLANNED. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15668915 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120857, K142084. One submission often covers many models, so check the product and lot details in each record.

• Z-1887-2019 · May 29, 2019 · Terminated
  EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, dis