Evolution G49652Recalls & reported problems
Cook Vandergrift Inc. · Evolution Shortie 11 Fr Mechanical Dilator Sheath Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00827002496521), received between Mar 22, 2017 and Mar 22, 2017 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
- Low Blood Pressure/ Hypotension1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A LEAD EXTRACTION/REMOVAL OF A PACEMAKER LEADS PROCEDURE. THE ATTENDING PHYSICIAN INDICATED IT WAS DIFFICULT TO GAIN ACCESS DUE TO CALCIFICATION AND FIBROSIS WHICH LEAD TO AN ADVERSE PHYSIOLOGICAL EVENT. IT WAS EVIDENT FROM THE ONSET THAT THESE LEADS WERE ENCAPSULATED WITH CALCIFICATION AND FIBROSIS. THE PHYSICIAN STRUGGLED TO PASS THROUGH THE VESSEL ENTRY SITE USING THE 1ST GENERATION OF EVOLUTION SHORTIE 11FR. MECHANICAL DILATOR SHEATH SET (LR-EVN-SH-11.0). THE PHYSICIAN THEN DISCUSSED THE POSSIBILITIES, AND DECIDED TO USE A GUIDE WIRE TO PASS DOWN THE LEAD FOR ACCESS IF NEEDED. THE ATTENDING PHYSICIAN FELT AN UNDESCRIBED POP AND SUDDEN MOVEMENT DURING THIS PROCESS. THE PATIENT WAS HYPOTENSIVE PRE-OPERATIVE WITH BLOOD PRESSURES OF 80/53 - 100/60. THE ATTENDING PHYSICIAN THEN DECIDED TO GO FEMORALLY AND GRAB THE LEADS. THE PATIENT'S BLOOD PRESSURE DROPPED TO 30 OVER NOTHING. THE PHYSICIAN CALLED A ¿CODE¿ TO OPEN THE CHEST AND A TEAR IN THE SUPERIOR VENA CAVA WAS DISCOVERED. THE CARDIAC SURGEONS REPAIRED THE TEAR, HOWEVER BLOOD WAS ADMINISTERED AS THE HEART WAS TOO DRY. AN ABUNDANT AMOUNT OF BLOOD WAS LOST AND THE CHEST
Patient problems: Blood Loss; Low Blood Pressure/ Hypotension; Perforation of Vessels
MAUDE report 6424065 ↗
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457490Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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