Amplatz Super Stiff™ M001465640Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
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 08714729295761), received between May 13, 2022 and Aug 12, 2024 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Detachment of Device or Device Component1
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.
MalfunctionAug 12, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED VIA ATTACHED VOLUNTARY MEDWATCH REPORT (B)(4). A 75CM .038 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS PLACED BY PHYSICIAN TO GUIDE THE NON-BOSTON SCIENTIFIC DRAIN. HOWEVER, UPON REMOVAL OF THE GUIDEWIRE, IT WAS UNABLE TO BE REMOVED. THE WIRE WAS REMOVED TOGETHER WITH THE DRAIN. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19967291 ↗MalfunctionMay 13, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE COATING DETACHED, AND THE GUIDEWIRE WAS DIFFICULT TO REMOVE. A 0.038IN X 75CM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A BILATERAL NEPHROSTOMY PROCEDURE ON A HIGH DEPENDENCY UNIT (HDU) PATIENT TO DRAIN THE KIDNEYS. DURING THE PROCEDURE, THE COATING BECAME DETACHED AT THE DISTAL SEGMENT, WHICH LEFT THE WIRE EDGY AND DIFFICULT TO USE. THE BARE WIRE WAS NOT SMOOTH AND WITHOUT THE COATING, IT WAS DIFFICULT TO RETRACT. NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14400446 ↗
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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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