Mailman™ Magnet H7491213601MJ0Recalls & reported problems
Boston Scientific Corporation · Guidewire with ICE™ Hydrophilic Coating · 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 08714729895985), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA FACILITY MEDWATCH# (B)(4) THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ATRIUM. DURING PACEMAKER LEAD ADDITION AND GENERATOR CHANGE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN POSITIONING THE LEFT VENTRICULAR (LV) LEAD IN APPROPRIATE BRANCH. SEVERAL GUIDEWIRE EXCHANGES OCCURRED TO ENGAGE THE PROPER POSITION. IT WAS OBSERVED THAT THE 182CM MAG J MAILMAN GUIDEWIRE DISTAL TIP BROKE OFF AND WAS IN THE VASCULATURE AROUND THE CORONARY SINUS. AN ATTEMPT TO REMOVE THE DEVICE FRAGMENT WAS MADE BUT GUIDEWIRE TIP WAS NOT RETRIEVABLE WITHOUT PERFORMING OPEN HEART SURGERY. IT WAS RECOMMENDED THAT THE DETACHED DISTAL TIP REMAIN INSIDE THE PATIENT AT THIS TIME BUT THERE WAS A RISK OF EMBOLIZATION. IT WAS EXPLAINED THAT MAGNETIC RESONANCE IMAGING (MRI) IS NOT RECOMMENDED WITH MAILMAN GUIDEWIRE AND THE PACEMAKER. THE PATIENT WAS REFERRED TO ANOTHER CARDIOLOGIST OR COMPUTED TOMOGRAPHY SURGEON FOR A SECOND OPINION FOR TREATMENT FOR THE DETACHED DISTAL GUIDEWIRE TIP. THE PROCEDURE WAS COMPLETED WITH A NEW LV LEAD AND ANOTHER LUGE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11732305 ↗
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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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