Single-Use Marked Spring Tip Guidewire DG-18-08-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06932503525114), received between Jun 20, 2022 and Oct 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT MONDAY, ON (B)(6) GI TECH (B)(6) AND DR. (B)(6) HAD AN ESOPHAGEAL PERFORATION WHILE USING MICROTECH'S SPRING TIP GUIDEWIRE. THE ACCOUNT WAS TRAILING MICROTECH'S GUIDEWIRE. (B)(6) SAID WHILE TEACHING THE DR WAS ADVANCING THE SAVORY 1:1 BETWEEN MARKING POINT 3 AND 4 ON THE GUIDEWIRE. THE PHYSICIAN FELT NO RESISTANCE DURING ADVANCEMENT OF SAVORY. THERE WAS A DENT OR KINK SEEN BETWEEN THE 3 AND 4 LANDING MARK ON OUR GUIDEWIRE. A PERFORATION OCCURRED AND THE PATIENT WAS ADMITTED AND IS RECOVERING AS EXPECTED. THE DR PLACED A 25MM BY 155 ESOPHAGEAL STENT. DURING THE TEAM DEBRIEF THE DR & TECH CONCLUDED THE GUIDEWIRE CAUSED TO THE PERFORATION.

  Patient problems: Perforation of Esophagus

  MAUDE report 20394683 ↗
• MalfunctionJun 20, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED TO MICRO-TECH(NANJING) CO.,LTD. THAT DR. BATTAGLINO WAS USING A SAVORY WITH GUIDEWIRE TO DILATE AND STATED THAT HE FELT RESISTANCE WITH ADVANCING THE SAVORY, SO REMOVED THE SAVORY WITH THE WIRE AND NOTICED THAT THE SPRING END OF THE WIRE WAS NO LONGER ATTACHED TO THE REST OF THE WIRE THAT HE REMOVED, SO THEN HAD TO GO BACK IN TO RETRIEVE THE BROKEN END. ONCE REENTERING, THEY FOUND THAT THE BROKEN END OF THE TIP THAT WAS RETAINED HAD PERFORATED THROUGH THE ESOPHAGUS AND POSSIBLY INTO OTHER TISSUE. THAT PIECE WAS THEN REMOVED AND THE CRNA OBTAINED AN ADVANCED AIRWAY AS HE THEN HAD A BLEED AND DID HAVE A CHANGE IN O2 SATURATION AND BLOOD PRESSURE. THE PATIENT WAS TRANSPORTED VIA EMS TO WAKE MED, WHERE HE UNDERWENT SURGICAL REPAIR OF THE PERFORATION. HERE ARE THE PHOTOS FROM THE WIRE THAT WAS USED. IT SEEMS TO HAVE BROKEN AT ONE OF THE DISTANCE MARKER SITES. REC FROM CUSTOMER ON 5/27/2022 - THANK YOU FOR LOOKING INTO THIS. AS OF NOW, PER DR. BATTAGLINO, THE PATIENT IS AWAKE AND HAS BEEN EXTUBATED, AND IS DOING MUCH BETTER AT THE MOMENT. HE DID HAVE SURGICAL REPAIR OF AN ESOPHAGEAL PERFORATION AND ALSO SUFFERED A PNEUMOTHORAX, REQUIRING CHEST TUBE PLACEMENT AS THE WIRE H

  Patient problems: Perforation of Esophagus

  MAUDE report 14741739 ↗