Amplatz Super StiffRecalls & reported problems across all models
Boston Scientific Corporation · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 295
- Deaths reported
- 3
- Injuries reported
- 32
- Recalls
- 0
We found 17 models of Amplatz Super Stiff by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 295 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Sep 16, 2026 — classified as 3 deaths, 32 injuries, 260 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (78 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Amplatz Super Stiff problems
Device problems
- Detachment of Device or Device Component78
- Adverse Event Without Identified Device or Use Problem72
- Material Integrity Problem65
- Unraveled Material53
- Break40
- Entrapment of Device35
- Difficult to Remove33
- Difficult to Advance27
Patient problems
- No Clinical Signs, Symptoms or Conditions198
- No Consequences Or Impact To Patient45
- No Known Impact Or Consequence To Patient19
- No Patient Involvement16
- Foreign Body In Patient9
- Hemorrhage/Blood Loss/Bleeding3
- Pericardial Effusion3
- Bradycardia2
Amplatz Super Stiff models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Amplatz Super Stiff™ M001465090WIRE, GUIDE, CATHETER64 reports
- Amplatz Super Stiff™ M001465240WIRE, GUIDE, CATHETER44 reports
- Amplatz Super Stiff™ M001465260WIRE, GUIDE, CATHETER32 reports
- Amplatz Super Stiff™ M001465020WIRE, GUIDE, CATHETER32 reports
- Amplatz Super Stiff™ M001465250WIRE, GUIDE, CATHETER22 reports
- Amplatz Super Stiff M0066401090STYLET FOR CATHETER, GASTRO-UROLOGY21 reports
- Amplatz Super Stiff M0066401080STYLET FOR CATHETER, GASTRO-UROLOGY18 reports
- Amplatz Super Stiff™ M001465230WIRE, GUIDE, CATHETER13 reports
- Amplatz Super Stiff™ M001465630WIRE, GUIDE, CATHETER12 reports
- Amplatz Super Stiff M0066401040STYLET FOR CATHETER, GASTRO-UROLOGY12 reports
- Amplatz Super Stiff™ M001465010WIRE, GUIDE, CATHETER2 deaths11 reports
- Amplatz Super Stiff M0066401060STYLET FOR CATHETER, GASTRO-UROLOGY1 death6 reports
- Amplatz Super Stiff™ M001465000WIRE, GUIDE, CATHETER2 reports
- Amplatz Super Stiff™ M001465640WIRE, GUIDE, CATHETER2 reports
- Amplatz Super Stiff M0066401050STYLET FOR CATHETER, GASTRO-UROLOGY2 reports
- Amplatz Super Stiff™ M001465200WIRE, GUIDE, CATHETER1 report
- Amplatz Super Stiff M00550090Endoscopic guidewire, gastroenterology-urology1 report
Recent Amplatz Super Stiff adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Difficult to Remove
It was reported that removal difficulty occurred.The non-stenosed target lesion was located in the severely tortuous and non-calcified thoracic descending aorta. An Amplatz Super Stiff guidewire was selected for use. During the procedure, a non-BSC stent graft was inserted into the guidewire lumen, however, it was very difficult to remove after the graft had been placed. The catheter and guide wire were removed separately. There were no patient complications as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788913 ↗MalfunctionSep 15, 2026Unsealed Device Packaging; Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779707 ↗MalfunctionSep 2, 2026Difficult to Remove
Patient problems: Pain
MAUDE report 50569609 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508394 ↗MalfunctionJul 29, 2026Nonstandard Device; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068757 ↗MalfunctionJun 24, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 035/260/1 AMPLATZ SUPER STIFF WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE WIRE WAS RINSED WITH SALINE OUTSIDE THE PATIENT. HOWEVER, THE TIP DETACHED WHEN IT WAS SHAPED. THE DEVICE WAS EXCHANGED PRIOR TO INTRODUCTION TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610845 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, AN AMPLATZ SUPER STIFF WAS USED, THE GUIDEWIRE WAS SHREDDED UPON OPENING DURING A CASE. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062215 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP WAS TORN OFF AND COULD NOT BE OPENED OCCURRED. A 035/260/3MM (B/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. A VISUAL SEPARATION WAS NOTED ON THE DEVICE PRIOR TO USE; THE DISTAL TIP WAS FOUND TORN OFF AND COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429584 ↗MalfunctionJan 15, 2026Nonstandard Device; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE HAD BECOME DETACHED. THE PROCEDURE INVOLVED AN ATRIAL SEPTAL DEFECT (ASD), AND A 035/260/1 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING DELIVERY, SIGNIFICANT RESISTANCE PREVENTED THE ADVANCEMENT OF THE GUIDEWIRE. UPON REMOVAL, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED AND BECOME INCOMPLETE DUE TO A DETACHMENT OF ITS LOOP; HOWEVER, IT DID NOT BREAK. THE PATIENTS ANATOMY WAS NOT CONSIDERED CHALLENGING, AND NEITHER PATIENT NOR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT. THE LESION EXHIBITED NO STENOSIS, TORTUOSITY, OR CALCIFICATION. THE DEVICE WAS REMOVED BY PULLING IT OUT DIRECTLY, WITH NO FRAGMENT LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079769 ↗MalfunctionDec 15, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE DURING AN INTERVENTIONAL THERAPY PROCEDURE FOR HEART DISEASE. THE TARGET LESION WAS IN A 50% STENOSED, NON-CALCIFIED, CHALLENGING BUT MILDLY TORTUOUS AORTA. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE GUIDEWIRE WAS REMOVED ALONG WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809427 ↗MalfunctionDec 15, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2025. AN 0.035IN X 260CM X 3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING INTRODUCTION, THE GUIDEWIRE COULD NOT CROSS THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING ON THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23807102 ↗MalfunctionDec 4, 2025Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE URETEROSCOPY PROCEDURE, THE PHYSICIAN TRIED TO PUT THE WIRE THROUGH THE STENT, IT UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CORE WIRE DETACHMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720517 ↗MalfunctionDec 3, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. IT WAS REPORTED THAT THE GUIDEWIRE KINKED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE WAS KINKED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE GUIDEWIRE COATING IS PEELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23712376 ↗MalfunctionDec 3, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. A 0.035IN X 260CM X 3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A PULMONARY ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING WAS PEELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710160 ↗MalfunctionDec 3, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. THE TARGET LESION WAS LOCATED IN THE COLON. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS USED TO ESTABLISH A CHANNEL TO THE COLON. THE STENT ENTERED ALONG THE GUIDEWIRE. HOWEVER, THE MIDDLE POSITION OF THE GUIDEWIRE WAS STUCK, AND THE STENT COULD NOT ENTER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING IS PEELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708880 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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