Spectre™ Guidewire 7386Recalls & reported problems
Vascular Solutions, Inc. · The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M20673860), received between Mar 22, 2018 and Apr 18, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Fracture2
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pericardial Effusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2018Detachment Of Device Component; Fracture; Detachment Of Device Component; Fracture
DURING ROUTINE PCI OF CORONARY ARTERY DR K USED SPECTRE WIRE AS A BUDDY WIRE TO DELIVER STENT. DR. TRAPPED/JAILED SPECTRE WIRE WITH STENT AND SPECTRE WIRE KNUCKLED, AND GOT STUCK ON DISTAL STRUTS OF STENT AND WAS BROKEN WHEN HE ATTEMPTED TO REMOVE SPECTRE GW. TIP OF SPECTRE WAS LEFT BEHIND IN VESSEL, AND A SECOND STENT WAS DEPLOYED TO COVER WIRE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7439311 ↗InjuryMar 22, 2018Fracture; Fracture
PHYSICIAN WIRED A DIAGONAL VESSEL THAT WAS 100 PERCENT OCCLUDED ISR WITHOUT ANY DIFFICULTY OR RESISTANCE. STENT WAS DELIVERED OVER WIRE WITH SUCCESS. DURING REMOVAL OF WIRE DISTAL PORTION OF WIRE IN DIAGONAL FRACTURED AND WAS LEFT IN THE VESSEL. PATIENT EXPERIENCED MASSIVE EFFUSION THUS GETTING A PERICARDIOCENTESIS. THE PLAN WAS TO LEAVE THE FRACTURED WIRE IN PLACE. THE PATIENT RECEIVED A PERICARDIOCENTESIS WITH 190 ML OF BLOOD REMOVED. CT SURGERY WAS CONSULTED AND WAS GOING TO MONITOR THE PATIENT BEFORE FURTHER SURGICAL INTERVENTION OR PERICARDIAL WINDOW. THE PORTION OF THE WIRE THAT WAS REMOVED FROM THE BODY WAS GIVEN TO THE DIRECTOR OF THE LAB FOR FACILITY RISK ANALYSIS. FOLLOW-UP PROCEDURE WAS/WERE PERFORMED S/P PERICARDIOCENTESIS. IT WAS REPORTED THE GUIDEWIRE WAS RETAINED IN THE PATIENT.
Patient problems: Pericardial Effusion
MAUDE report 7363982 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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