SafeGuide® 1214-02DRecalls & reported problems
Diversatek Healthcare, Inc. · Guidewire with Spring Tip - Single Use · 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 00816734021507), received between Nov 30, 2021 and Sep 30, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Activation, Positioning or Separation Problem1
- Device Damaged by Another Device1
- Difficult to Insert1
- Mechanical Problem1
Patient problems
- Laceration(s) of Esophagus2
- Perforation of Esophagus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2024Mechanical Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Mechanical Problem; Difficult to Remove; Activation, Positioning or Separation Problem
CUSTOMER REPORTED EVENT TO MANUFACTURER ON SEPTEMBER 04, 2024. CUSTOMER REPORTED THAT THE SPRING TIP OF THE GUIDEWIRE BENT IN SUCH A WAY AFTER DILATION THAT IT LED TO THE PERFORATION OF THE PATIENT'S ESOPHAGUS. THE BEND TO THE SPRING TIP FORMED A V-SHAPE. THE ACUTE BEND OF THE WIRE DUG INTO THE PATIENTS ESOPHAGUS UPON REMOVAL OF THE WIRE. THE ESOPHAGUS WAS PERFORATED AS A RESULT OF REMOVAL WITH THE EXTREME BEND TO THE TIP. SURGICAL INTERVENTION WAS NEEDED TO REPAIR THE PERFORATION. THE PATIENT WAS HOSPITALIZED FOR AN UNDISCLOSED AMOUNT OF TIME.
Patient problems: Laceration(s) of Esophagus; Perforation of Esophagus
MAUDE report 20333114 ↗InjuryNov 30, 2021Difficult to Insert; Difficult to Remove; Device Damaged by Another Device; Difficult to Insert; Difficult to Remove; Device Damaged by Another Device
CUSTOMER REPORTED EVENT TO MANUFACTURER ON NOVEMBER 1, 2021. CUSTOMER REPORTED THE GUIDEWIRE BENT WHICH LED TO THE PERFORATION OF THE PATIENT'S ESOPHAGUS. THE GUIDEWIRE FORMED A V-SHAPE. THE ACUTE BEND OF THE WIRED WAS LODGED IN THE WALL OF THE ESOPHAGUS. THE ESOPHAGUS TORE UPON REMOVAL OF THE WIRE. SURGICAL INTERVENTION WAS NEEDED TO REPAIR THE PERFORATION AND PLACE AN ESOPHAGEAL STENT WITH BILATERAL CHEST DRAINAGE TUBES. THE PATIENT WAS HOSPITALIZED FOR 6 DAYS FOLLOWING THE EVENT.
Patient problems: Laceration(s) of Esophagus; Perforation of Esophagus
MAUDE report 12903472 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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