CardioMEMS™ GuidewireRecalls & reported problems
Cardiomems, Inc. · 0.018 in / 260 cm · Class 2
Data updated Oct 18, 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 05414734509565), received between Mar 28, 2019 and Mar 28, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
- Difficult to Advance1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2019Break; Break
IT WAS REPORTED DURING THE SENSOR IMPLANT PROCEDURE, THE GUIDEWIRE SNAPPED INSIDE THE SWAN WHILE THE PHYSICIAN WAS TRYING TO ADVANCE INTO THE IMPLANT SITE. THE ISSUE WAS OBSERVED PRIOR TO THE INTRODUCTION OF THE CARDIOMEMS DELIVERY SYSTEM. REPORTEDLY, THE PHYSICIAN WAS ABLE TO SNARE THE TWO PIECED OUT AND SUCCESSFULLY IMPLANT THE SENSOR AND CALIBRATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8460725 ↗InjuryMar 28, 2019Break; Difficult to Advance; Break; Difficult to Advance
IT WAS REPORTED DURING THE SENSOR IMPLANT PROCEDURE, THE GUIDEWIRE STOPPED ADVANCING THROUGH THE SWAN AND THE DISTAL TIP BROKE OFF DURING PULL BACK. THE ENTIRE WIRE WAS ABLE TO BE RETRIEVED. REPORTEDLY, THE PHYSICIAN WAS ABLE TO COMPLETE THE IMPLANT WITH A NEW GUIDEWIRE WITHOUT ANY PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8460667 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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