SPECTRE IPN913605Recalls & reported problems
Teleflex Incorporated · Spectre Guidewire 300cm · Class 2
Data updated Oct 16, 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 10841156101145), received between Apr 14, 2021 and Apr 14, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Extravasation1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A CTO PCI INDEX PROCEDURE FOR THE CTO-PCI STUDY OF A SEVERELY CALCIFIC NON-TORTUOUS LESION LOCATED IN THE PROX. LAD, THE SUBJECT SUFFERED AN ELLIS I PERFORATION. MANY DEVICES WERE USED DURING THE PROCEDURE, BOTH STUDY AND NON-STUDY AND IT WAS FELT THAT PERFORATION WAS DUE TO CATHETER COURSE, BUT IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION. STUDY DEVICES USED IN THE PROCEDURE INCLUDED A TURNPIKE SPIRAL MICROCATHETER, SPECTRE 200 CM AND 300 CM GUIDEWIRES, A RAIDER GUIDEWIRE, AND A WARRIOR GUIDEWIRE. SUBJECT SHOWED NO SIGNS OR SYMPTOMS OVERTLY AND POSSIBLE EXTRAVASATION WAS NOTED ON ONE ANGIOGRAM. PROLONGED BALLOON INFLATION WAS PERFORMED IN SUSPECTED AREA PROPHYLACTICALLY, BUT NOT SPECIFICALLY FOR TAMPONADE OR PERFORATION, PROTAMINE WAS ADMINISTERED TO REVERSE ANTICOAGULATION. POST-PROCEDURE TEE SHOWED NO EFFUSION. SUBJECT DISCHARGED HOME NEXT DAY, RESOLVED WITHOUT FURTHER SEQUELAE. NO ADVERSE EVENTS WERE REPORTED AT STUDY 30-DAY FOLLOW-UP VISIT. ASSOCIATED MDRS: MDR 2134812-2021-00037 RAIDER GUIDEWIRE. MDR 2134812-2021-00038 SPECTRE GUIDEWIRE. MDR 2134812-2021-00040 TURNPIKE SPIRAL. MDR 2134812-2021-00041 WARRIOR GUIDEWIRE.
Patient problems: Extravasation; Perforation
MAUDE report 11668312 ↗
Other Wire, guide, catheter devices
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- 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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