SPECTRE IPN913604Recalls & reported problems
Teleflex Incorporated · Spectre Guidewire 190cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841156101138), received between Aug 4, 2020 and May 24, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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. 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
- Break1
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Foreign Body Embolism1
- No Known Impact Or Consequence To Patient1
- Perforation1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2021Break; Break
AS REPORTED: THE WIRE WAS CAUGHT IN A STENT. AFTER MULTIPLE ATTEMPTS TO GET IT OUT, IT BROKE OFF. ADDITIONAL INFORMATION RECEIVED: 14MAY2021: LOOKS LIKE THE WIRE WAS KNUCKLED AND WHEN STENT WAS DEPLOYED THE TIP WAS UNDER STENT. THE RCA WAS THE VESSEL BEING FIXED AND THE SPECTRE WIRE WAS BROKE OFF IN THE VESSEL. A MICROCATHETER WAS USED TO TRY AND RELEASE WIRE AND WAS UNSUCCESSFUL, SO THEN WIRE WAS PULLED WITH THE ASSIST OF MICROCATHETER TO BREAK. THE MARKED TIP OF WIRE WAS BROKEN OFF. NO SNARE WAS USED BECAUSE SOME OF IT WAS STILL STUCK IN PRIOR STENT DEPLOYED. ANOTHER STENT WAS USED TO HOLD THE REST OF THE WIRE DOWN AGAINST VESSEL.
Patient problems: Foreign Body Embolism
MAUDE report 11871866 ↗InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: AT THE COMPLETION OF THE SUCCESSFUL INDEX PROCEDURE ON CTO PCI STUDY IT WAS NOTED THAT THERE WAS A SMALL (ELLIS GRADE II) DISTAL WIRE PERFORATION IN THE PLV BRANCH CAUSED BY THE SPECTRE WIRE. PERFORATION TREATED WITH 30-MINUTE PROLONGED BALLOON OCCLUSION WITH NO RESIDUAL PERFORATION NOTED. ALL CORONARY EQUIPMENT/DEVICES REMOVED, AND PROTAMINE WAS ADMINISTERED TO REVERSE ANTICOAGULATION. BEDSIDE ECHOCARDIOGRAM SHOWED NO EFFUSION. THIS EVENT WAS RESOLVED WITH NO SEQUELAE ON (B)(6) 2020. SUBJECT DISCHARGED TO HOME ON (B)(6) 2020 IN GOOD CONDITION.
Patient problems: Perforation
MAUDE report 11010925 ↗InjuryAug 4, 2020Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
IT WAS REPORTED DURING A PCI OF THE RCA THAT THE TIP OF THE SPECTRE WIRE BROKE OFF IN VESSEL. PHYSICIAN WAS UNABLE TO SNARE IT OUT FOR REMOVAL. REMAINING PORTION STENTED AGAINST WALL AND LEFT IN VESSEL. PRODUCT WAS DISCARDED SO THERE IS NOTHING TO RETURN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient; Vessel Or Plaque, Device Embedded In
MAUDE report 10362718 ↗
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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