Amplatz Super Stiff™ M001465000Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
All models of Amplatz Super Stiff (17)
Data updated Oct 18, 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 08714729295631), received between Mar 8, 2023 and Jan 31, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Difficult to Remove1
- Material Deformation1
- 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.
MalfunctionJan 31, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE SEPARATED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A BILIARY DRAINAGE PROCEDURE. AN 8.5 FRENCH NON-BOSTON SCIENTIFIC DRAINAGE CATHETER FOR INTERNAL AND EXTERNAL BILIARY DRAINAGE WAS USED, EQUIPPED WITH A SOFT MANDRIN. AFTER CORRECTLY POSITIONING THE DRAIN, AN ISSUE AROSE WHILE ATTEMPTING TO SIMULTANEOUSLY PULL OUT THE SOFT MANDRIN AND THE AMPLATZ SUPER STIFF GUIDEWIRE. RESISTANCE WAS ENCOUNTERED DURING REMOVAL, BUT THE USER CONTINUED TO PULL THE MANDRIN AND THE GUIDEWIRE OUT TOGETHER. UPON EXTRACTING THE MANDRIN AND GUIDEWIRE, IT WAS OBSERVED THAT THE SOFT MANDRIN HAD STRETCHED DURING THE REMOVAL PROCESS. ULTIMATELY, A PORTION OF THE MANDRIN WAS LEFT INSIDE THE DRAINAGE CATHETER, AND THE AMPLATZ SUPER STIFF GUIDEWIRE HAD DISINTEGRATED, SEPARATING INTO TWO PIECES BUT REMAINING CONNECTED AT THE MIDPOINT. BOTH DEVICES WERE SUCCESSFULLY RETRIEVED FROM THE DRAIN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21286860 ↗MalfunctionMar 8, 2023Unraveled Material; Detachment of Device or Device Component; Material Deformation; Unraveled Material; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT CORE WIRE DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON- TORTUOUS AND NON-CALCIFIED FEMORAL ARTERY. A 035/145/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED, HOWEVER, IT WAS FOUND UNDER FLUOROSCOPY THAT THE TIP WAS SERIOUSLY KINKED. THE PHYSICIAN PULLED THE WIRE BACK OUT OF THE SHEATH AND INSPECTED IT. THE OUTER SUPPORT COIL WAS LOOSENED, AND THE INNER CORE WIRE OF AMPLATZ WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16507247 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 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.
How reports and recalls are matched · Editorial policy · Report an error on this page