Vanguard 6200x135Recalls & reported problems
Contego Medical, Inc. · The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851616007149), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
- Mechanical Problem1
Patient problems
- Unspecified Vascular Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Mechanical Problem; Mechanical Problem
ONE PATIENT INVOLVED. DR (B)(6) WAS TREATING A DIFFUSIVELY DISEASED SFA WITH SIGNIFICANT CALCIUM IN A PATIENT WITH SINGLE VESSEL RUNOFF HE DECIDED TO USE A VANGUARD 6X200MM TO PREVENT ANY DISTAL EMBOLI HE DID TWO SEPARATE INFLATIONS IN THE DISEASED VESSEL AFTER HE WAS SATISFIED WITH THE RESULT WAS FULLY DEFLATED, HE CLOSED THE FILTER AND BEGAN TO WITHDRAW THE DEVICE-AS FILTER MET THE 6FR SHEATH HE GOT SIGNIFICANT RESISTANCE COMING INTO THE SHEATH. -DR (B)(6) REPOSITIONED THE CATHETER AND SHEATH A FEW TIMES UNDER FLUORO AND WAS STILL HAVING TROUBLE PULLING CATHETER INTO THE SHEATH AT SOME POINT HE REALIZED THE FILTER WAS DEFORMED AND COULD NOT EXIT THE SHEATH. HE DECIDED TO PULL THE ENTIRE SHEATH AND VANGUARD CATHETER OUT THROUGH THE ACCESS SITE. HE WAS UNABLE TO DO SO AND HE ALSO NOTICED AT THIS POINT THE FILTER HAD DETACHED FROM THE CATHETER DR (B)(6) WENT IN AND TRIED SEVERAL MANEUVERS TO GET THE NOW DETACHED FILTER OUT OF THE VESSEL TO NO AVAIL. AT THIS POINT HE HAD DONE ENOUGH TO HAVE THE FILTER, WHICH WAS NOW JUST A WIRE PRESSED AGAINST THE WALL OF THE COMMON FEMORAL, NOT OBSTRUCTING FLOW AT ALL.-DR (B)(6) LEFT THIS AND HIS PLAN AS HE STATED WAS TO MOST LIKELY GO BACK IN WHEN
Patient problems: Unspecified Vascular Problem
MAUDE report 19956803 ↗
Other Catheter, Angioplasty, Peripheral, Transluminal devices
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- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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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