ATTAIN HYBRID™ Guide Wire GWR419578Recalls & reported problems
Medtronic, Inc. · GUIDE WIRE GWR419578 98CM GLOBAL CE · Class 2
Data updated Oct 18, 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 00643169452428), received between Sep 27, 2024 and Sep 27, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN REPORTED FEELING NO UNDUE PRESSURE WHEN ATTEMPTING TO ADVANCE THE LEFT VENTRICULAR (LV) LEAD AND GUIDEWIRE. THE GUIDEWIRE APPEARED TO FOLLOW THE PATH OF THE TARGET BRANCH OF THE CORONARY SINUS. THE INJECTION OF CONTRAST SHOWED THAT THERE WAS A PERFORATION AND THE CONTRAST WAS ACCUMULATING IN THE PERICARDIAL SPACE. THE LEAD AND GUIDEWIRE WERE WITHDRAWN AND A PERICARDIOCENTESIS WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation of Vessels; Pericardial Effusion
MAUDE report 20324981 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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