Byrd G26514Recalls & reported problems
Cook Vandergrift Inc. · 13.0 Fr Byrd Dilator Sheath Set (D) Polypropylene · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002265141), received between Sep 8, 2025 and Sep 8, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Perforation of Vessels1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MAN IN HIS 70S, LEAD REMOVAL INDICATED DUE TO INFECTION AFTER PLACED FOR 25 YEARS. PLACED FROM THE RIGHT CHEST. PACEMAKER LEADS WERE EMBEDDED IN BOTH THE ATRIUM AND VENTRICLE. THE LOCKING STYLET USED WAS LR-OFA01 FOR BOTH. THE ATRIAL LEAD CAN BE REMOVED USING A 12FR LASER AND A 14FR LASER. THE VENTRICULAR LEAD HAD STRONG ADHESION AT THE TIP OF THE LEAD, AND ALTHOUGH THE SHEATH COULD REACH THE TIP OF THE LEAD USING EVOLUTION 11FR AND EVOLUTION 13FR, IT COULD NOT BE REMOVED FROM THE APEX OF THE HEART. THE PROCEDURE TOOK A LONG TIME AND THE LEAD STRETCHED, AND IT BROKE WHILE USING EVOLUTION 13FR. (THE STATE OF OFA COULD NOT BE CONFIRMED) THE LEAD HAD STRETCHED AND THINNED, AND WAS OUTSIDE THE BODY, SO A LONG THREAD (SIZE 2-0 OF SILK THREAD) WAS TIED TO IT AND USED AS A ROUTE TO PASS THE SHEATH FOR FREEING THE LEAD FROM THE ADHESIVE TISSUE. A 6FR MULTIPURPOSE CATHETER WAS PASSED THROUGH THE THREAD, AND A PPLBES7.0XL OUTER SHEATH WAS PLACED OVER IT, AND A PPLBES13 INNER SHEATH AND OUTER SHEATH WERE PLACED OVER THAT, AND THE PHYSICIAN ATTEMPTED TO FREE THE LEAD FROM THE ADHESIVE TISSUE. THE OPERATOR COMMENTED THAT "THE TIP OF THE SHEATH POKED THE VENTRICLE," AND LATER NOTED THE ACCUMUL
Patient problems: Cardiac Perforation; Perforation of Vessels; Pericardial Effusion
MAUDE report 22993264 ↗
Other Dilator, catheter devices
- Byrd G19860Cook Vandergrift Inc. · Dilator, catheter1 death2 reports
- Byrd G19859Cook Vandergrift Inc. · Dilator, catheter2 reports
- Salivary Access Dilator Set SDDS-18-20-HCC2dx, Inc. · Dilator, Catheter1 report
- Screw Dilator 630838025Argon Medical Devices, Inc. · Dilator, Catheter1 report
- NA M0062601070Boston Scientific Corporation · Dilator, catheter1 report
- NA M001481540Boston Scientific Corporation · Dilator, catheter1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.