SafeGuide® 1214-02Recalls & reported problems
Diversatek Healthcare, Inc. · Guidewire with Spring Tip · 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 00816734020975), received between Apr 10, 2019 and Apr 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Migration1
Patient problems
- Patient Problem/Medical Problem1
- Perforation of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2019Material Deformation; Migration; Material Deformation; Migration
DURING AN ESOPHAGOGASTRODUODENOSCOPY SAVORY DILATROES WITH GUIDE-WIRE WAS USED. GUIDE-WIRE COULD NOT BE REMOVED. IMAGING STUDIES REVEALED GUIDE WIRE KINKED OUTSIDE OF ESOPHAGUS WITH SMALL PNEUMOTHORAX. PATIENT TRANSFERRED TO A HIGHER LEVEL OF CARE FACILITY. CARDIOTHORACIC SURGERY PERFORMED TO EXTRACT THE WIRE
Patient problems: Patient Problem/Medical Problem; Perforation of Esophagus
MAUDE report 8502004 ↗
Other Dilator, Esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 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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