Stainless Steel Guidewire M001201080Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 1
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 08714729735144), received between Sep 6, 2018 and Dec 16, 2020 — classified as 2 injuries.
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
Device problems
- Break1
- Fracture1
Patient problems
- Death1
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2020Break
PIECE OF GUIDEWIRE BROKE OFF IN PT. PER INCIDENT REPORT: "WHILE PROVIDER ATTEMPTING TO PLACE NEPHROSTOMY TUBE USING A GUIDE WIRE," STAINLESS STEEL" 7.5 CM BROKE PART OF THE WIRE OFF INSIDE THE RIGHT KIDNEY. MD ATTEMPTED TO SNARE WIRE WITH NO SUCCESS. PT EXPIRED ON (B)(6) 2020. CODE WAS STOPPED AT 2047 PER NURSING DOCUMENTATION.
Patient problems: Death; Foreign Body In Patient
MAUDE report 11019023 ↗InjurySep 6, 2018Fracture; Fracture
IT WAS REPORTED THAT THE WIRE BROKE AND REMAINED INSIDE PATIENT'S BODY. AN ACCUSTICK STAINLESS STEEL GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ACCUSTICK GUIDEWIRE BROKE OFF IN THE PATIENT'S BODY IN THE RENALCALYX /RETROPERITONEUM. THE PHYSICIAN MADE ATTEMPTS TO RETRIEVED THE DETACHED PORTION OF THE WIRE, HOWEVER, FAILED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION POST-PROCEDURE WAS OKAY. IT WAS FURTHER REPORTED APPROXIMATELY 1 CM OF THE GUIDEWIRE REMAINED IN THE BODY IN THE RENAL CALYX / RETRO PERITONEUM.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7853207 ↗
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- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 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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