Amplatz Super Stiff™ M001465250Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729295730), received between Apr 26, 2019 and Nov 5, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (13 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE KIDNEY. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A URETEROSCOPY. DURING THE PROCEDURE, THE COATING OF THE BODY OF WIRE STARTED PEELING. NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478755 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ SUPER STIFF GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438521 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ SUPER STIFF GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438507 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ SUPER STIFF GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438504 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ SUPER STIFF GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437259 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ SUPER STIFF GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437252 ↗
• MalfunctionJul 7, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON 7 AMPLATZ - PI GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418910 ↗
• MalfunctionApr 4, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN AMPLATZ SUPER STIFF WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, ADVANCEMENT OF THE AMPLATZ WIRE WITHIN THE PATIENT PROVED CHALLENGING. UPON REMOVAL OF THE WIRE, IT WAS OBSERVED THAT THE COATING HAD BECOME BUNCHED UP AND EXHIBITED A LUMPY TEXTURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774046 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COATING PEELED. A 0.035IN X 180CM STRAIGHT TIP AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM PROCEDURE. HOWEVER, DURING THE INITIAL MANIPULATION OF THE GUIDEWIRE UNDER FLUOROSCOPY, THE DISTAL END OF THE GUIDEWIRE HAD BECOME SPLIT. THE COATING HAD PEELED. THE DEVICE WAS CAREFULLY REMOVED IN ONE PIECE. IT WAS CONFIRMED NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ SUPER STIFF GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546884 ↗
• MalfunctionJul 17, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20JUN2024. IT WAS REPORTED THAT GUIDEWIRE KINKED OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE LOWER EXTREMITY ARTERY. A S/S XCH/035/180 (BX/5) AMPLATZ SUPER STIFF WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE DISTAL TIP OF THE GUIDEWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A CORE WIRE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766607 ↗
• MalfunctionFeb 1, 2023Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09 JAN 2023. IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A BILIARY DRAINAGE CATHETER EXCHANGE. DURING THE PROCEDURE, THE AMPLATZ SUPER STIFF GUIDEWIRE UNRAVELED. THE DEVICE WAS EXCHANGED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CORE WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281074 ↗
• InjuryDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH 5113264 THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 035/180 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS USED FOR A VASCULAR CASE. HOWEVER, DURING WITHDRAWAL, THE TIP OF THE GUIDEWIRE PULLED OFF AND WAS LOOSE IN THE GROIN. THE DETACHED TIP WAS LOCATED, AND X-RAY CONFIRMED THAT NO FURTHER PIECES OF GUIDEWIRE WAS RETAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15960523 ↗
• MalfunctionFeb 17, 2022Break; Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERIPHERAL INTERVENTION AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN THE URETER AND BLADDER DURING A PERCUTANEOUS URETERIC STENT. PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE THE GUIDEWIRE WENT INTO THE BLADDER FAIRLY EASILY, A 9F SHEATH TIP IN THE UPPER URETER, AND AN 8F 26CM PERCUFLEX STENT INSERTED OVER THE WIRE. ALL COMPONENTS WERE FLUSHED WITH SALINE. THERE WAS DIFFICULTY WITHDRAWING THE INNER STIFFENING CATHETER FROM PUSHER AND STENT; IT WAS PARTLY OUT WHEN THE HUB CAME OFF THE STIFFENING CATHETER. IT FELT LIKE IT WAS STUCK ON THE WIRE. EVERYTHING WAS PULLED BACK INTO THE SHEATH. UPON EXAMINATION OUTSIDE THE BODY, THE WIRE HAD PARTLY FALLEN APART WITH A FRAGMENT STICKING THROUGH THE STIFFENING CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CORE WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548535 ↗
• MalfunctionNov 8, 2021Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THE GUIDEWIRE BECAME CAUGHT ON THE DEPLOYED STENT. A 10MM X 68MM VENOUS SELF-EXPANDING WALLSTENT AND A 0.035 X 180 CM AMPLATZ SUPERSTIFF STRAIGHT TIP GUIDEWIRE WERE SELECTED FOR USE IN A RECANALIZATION PROCEDURE. THE WALLSTENT WAS LOADED ONTO THE AMPLATZ GUIDEWIRE. AFTER THE WIRE WAS PLACED WITHIN THE STENT DELIVERY SYSTEM, A BURR WAS OBSERVED ON THE GUIDEWIRE. THE BURR SNAGGED AND THEN DAMAGED THE STENT CATHETER. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775255 ↗
• MalfunctionOct 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CLAUDICATION AND UNDERWENT A LEFT LEG ANGIOGRAM. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY. AFTER AN S/S XCH/035/180 AMPLATZ SUPER STIFF GUIDEWIRE WAS CROSSED THE LESION. A 10.0 X 40 X 75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE DEPLOYMENT OF THE STENT, THE ENTIRE DEVICE WAS CRIMPED AND THE GUIDEWIRE FRAYED. THE PHYSICIAN THEN DEPLOYED AN ADDITIONAL EXPRESS LD ILIAC / BILIARY STENT TO COVER IT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703186 ↗
• InjuryMay 28, 2021Entrapment of Device; Fracture; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Fracture; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GUIDEWIRE BECAME STUCK IN A DEVICE, BECAME UNRAVELED AND FRACTURED WITH THE TIP BECOMING STUCK IN A NON-BOSTON SCIENTIFIC ANCILLARY DEVICE. THE PATIENT EXPERIENCED PERFORATION, SHOCK AND ELECTRO-MECHANICAL DISSOCIATION. ADDITIONAL INTERVENTION WAS PERFORMED AND AN ADDITIONAL PROCEDURE ON A LATER DATE WAS ALSO PERFORMED, TO REMOVE THE DEVICES. AN AMPLATZ SUPER STIFF .035IN X 180CM GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS NEPHROSTOMY PROCEDURE IN THE KIDNEY TO TREAT A PATIENT WITH A TUMOR BLOCK OF THE PELVIS WITH TWO OCCLUDED URETERS. THE TUMOR WAS REPORTED AS EXTENSIVE PELVIC AND RETROPERITONEAL, ADENOPATHIES COMPRESSING THE RIGHT URETER. A NON-BOSTON SCIENTIFIC JJ CATHETER WAS PLACED THROUGH THE NEPHROSTOMY PORT AND WHEN THE GUIDEWIRE WAS TRIED TO REARRANGE, IT WAS NOTED THAT THE LAST FEW CENTIMETERS OF THE WIRE BECAME STUCK IN THE JJ CATHETER. DESPITE APPROXIMATELY 10 MINUTES OF REMOVAL ATTEMPTS, THE FLEXIBLE END OF THE GUIDEWIRE BROKE AND IT WAS SUSPECTED THAT A FRAGMENT REMAINED IN THE NEPHROSTOMY. THE PHYSICIAN CHOSE TO END THE PROCEDURE AND PATIENT WENT INTO HYPOVOLEMIC SHOCK DURING TRANSFER TO A BED. ADDITIONALLY, ELECTRO-M

  Patient problems: Arrhythmia; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Perforation of Vessels

  MAUDE report 11903173 ↗
• MalfunctionApr 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. A 035/180 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL, IT WAS NOTED THAT THE OUTER COATING PART OF THE WIRE SHEARED OFF. THE DEVICE WAS COMPLETELY RETRIEVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695322 ↗
• InjuryAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A PROCEDURE AND DURING THE PROCEDURE, THE TIP DETACHED FROM THE WIRE WHILE INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370252 ↗
• MalfunctionJul 27, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE FRAYED. A 035/180 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE END OF THE WIRE WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325579 ↗
• MalfunctionApr 29, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING REMOVAL FROM THE PATIENT, THE GUIDWIRE FELT STUCK. THE GUIDEWIRE WAS REMOVED; HOWEVER IT WAS A LITTLE BIT LONGER AND IT APPEARED THAT PART OF THE WIRE WAS LACED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009419 ↗
• MalfunctionNov 4, 2019Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DISTAL TIP OF GUIDEWIRE DETACHMENT OCCURRED. A 0.035IN X 180CM AMPLATZ SUPER STIFF GUIDEWIRE SELECTED FOR USE FOR A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DUE TO PATIENT'S KIDNEY BEING FULL OF STONES, THE AMPLATZ GUIDEWIRE HAD DIFFICULTY TO ADVANCING THROUGH THE KIDNEY TO THE BLADDER. AFTER MULTIPLE ATTEMPTS, THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. THE RADIOLOGIST NOTICED THE DISTAL TIP OF THE GUIDEWIRE WAS DAMAGED AND A PORTION OF THE DISTAL TIP WAS MISSING. THE DETACHMENT OF THE DISTAL TIP CONFIRMED BY MEASURING THE AMPLATZ GUIDEWIRE. SEVERAL BAGS OF SALINE FOR IRRIGATION WERE USED TO HELPED FLUSH OUT THE DETACHMENT PORTION OF THE AMPLATZ GUIDEWIRE. AT THE END OF THE PROCEDURE, THE PHYSICIAN X-RAYED THE PATIENT TO CONFIRM NOTHING WAS LEFT BEHIND. IT WAS CONCLUDED THAT MISSING PORTION OF THE AMPLATZ GUIDEWIRE WAS FLUSHED OUT. THE PROCEDURE COMPLETED BY USING NEPHROSCOPE AND ULTRASOUND TO BREAK THE KIDNEY STONES. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274445 ↗
• MalfunctionApr 26, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT STERILITY WAS COMPROMISED. A 035/180 AMPLATZ SUPER STIFF GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGE. THE DEVICE WAS NEVER USED IN A PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8557543 ↗