SHEATH INTRO KIT 6FR L5 MULT=5/50 680128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333601288), received between Aug 13, 2020 and Aug 13, 2020 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT ST ELEVATION MYOCARDIAL INFARCTION [STEMI] INTERVENTION, REQUIRING AN EMERGENT LEFT & RIGHT HEART HEMODYNAMIC EVALUATION FOR A PATIENT IN CARDIOGENIC SHOCK. THE PHYSICIAN ATTEMPTED TO ACQUIRE VASCULAR ACCESS TO THE PATIENT'S RIGHT ATRIUM WITH A THERMODILUTION [TD] CATHETER TO ACQUIRE THE PRESSURES NECESSARY TO EFFECTIVELY EVALUATE RIGHT HEART AND LUNG FUNCTION. THE 7F TD CATHETER WOULD NOT FIT THOUGHT THE VALVE OF THE 8F ACCESS SHEATH. THE INNER LUMEN OF THE SHEATH WAS TOO TIGHT, THE PHYSICIAN COULD NOT ACQUIRE ACCESS TO THE PATIENT'S RIGHT HEART CHAMBERS. THE PHYSICIAN QUICKLY EXCHANGED THE ACCESS SHEATH TO SUCCESSFULLY ACQUIRE HEART AND LUNG EVALUATIONS WITH THE TD CATHETER. THE PATIENT WAS TRANSFERRED POST-PROCEDURE TO ICU FOR CONTINUED MONITORING.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 10403541 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT ST ELEVATION MYOCARDIAL INFARCTION [STEMI] INTERVENTION, REQUIRING AN EMERGENT LEFT & RIGHT HEART HEMODYNAMIC EVALUATION FOR A PATIENT IN CARDIOGENIC SHOCK. A 5F TEMPORARY PACEMAKER WIRE WOULD NOT ADVANCE THROUGH THE VALVE OF A 6F ACCESS SHEATH. THE PHYSICIAN STATES THAT THE FIT WAS TOO TIGHT AND WOULD NOT ALLOW THE PACING WIRE TO ADVANCE THROUGH TO THE PATIENT'S VASCULATURE TO THE TARGETED RIGHT VENTRICLE. THE PHYSICIAN QUICKLY EXCHANGED THE SHEATH TO SUCCESSFULLY ACQUIRE ACCESS NEEDED TO PLACE THE TEMPORARY PACEMAKER FOR THE PATIENT. THE PATIENT WAS TRANSFERRED POST-PROCEDURE TO ICU FOR CONTINUED MONITORING.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 10403533 ↗