Amplatz Super Stiff M0066401050Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 1
All models of Amplatz Super Stiff (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729752677), received between Jun 9, 2021 and Dec 12, 2023 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Peeled/Delaminated1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A PC TJ LIVER BIOPSY PROCEDURE IN THE LIVER PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS FOUND THAT THE COATING WIRE WAS STRIPPED, AND THEN THEY TOOK OF THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AMPLATZ SUPER STIFF DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE CORE WIRE WAS DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314320 ↗MalfunctionJun 9, 2021Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN THE UERETER IN A CYSTOCOPY WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2021. DURING PREPARATION, WHEN THE PHYSICIAN WAS WITHDRAWING THE GUIDEWIRE, IT UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE DETACHED FROM THE SOLDER BALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11964513 ↗
Other STYLET FOR CATHETER, GASTRO-UROLOGY devices
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- Sensor M0066703080Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY118 reports
- Sensor M0066703050Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY41 reports
- Bard® Hydro-Glide™ Guidewire 145FS35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY31 reports
- NiCore Nitinol Guidewire 150NFS35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY30 reports
- Amplatz Super Stiff M0066401090Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY21 reports
- Amplatz Super Stiff M0066401080Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY18 reports
- Sensor M0066703120Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY17 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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