Platinum PlusRecalls & reported problems across all models

We found 10 models of Platinum Plus by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Apr 3, 2018 and Sep 11, 2025 — classified as 21 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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

Most reported Platinum Plus problems

Platinum Plus models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Platinum Plus™ M001467120

  WIRE, GUIDE, CATHETER
  21 reports
• Platinum Plus™ M001467320

  WIRE, GUIDE, CATHETER
  11 reports
• Platinum Plus™ M001466050

  WIRE, GUIDE, CATHETER
  9 reports
• Platinum Plus™ M001466020

  WIRE, GUIDE, CATHETER
  5 reports
• Platinum Plus™ M001466040

  WIRE, GUIDE, CATHETER
  5 reports
• Platinum Plus™ M001466100

  WIRE, GUIDE, CATHETER
  2 reports
• Platinum Plus™ M001467310

  WIRE, GUIDE, CATHETER
  2 reports
• Platinum Plus™ M001466010

  WIRE, GUIDE, CATHETER
  1 report
• Platinum Plus™ M001466110

  WIRE, GUIDE, CATHETER
  1 report
• Platinum Plus™ H74917530

  WIRE, GUIDE, CATHETER
  1 report

Recent Platinum Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP WAS SHREDDED UPON OPENING THE PACKAGE. A PLATINUM PLUS - PI GUIDEWIRE WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE TIP OF THE WIRE WAS OBSERVED TO BE SHREDDED UPON OPENING THE PACKAGE AND THE DEVICE COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031397 ↗
• MalfunctionJul 18, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. IT WAS DIFFICULT TO ADVANCE THE CAROTID WALLSTENT DELIVERY SYSTEM OVER THE GUIDEWIRE TO REACH THE TARGET LESION. THE STENT WAS DEPLOYED IN THE TARGET LESION WITHOUT ISSUE. FOLLOWING DEPLOYMENT, THE PHYSICIAN WAS UNABLE TO RETRACT THE STENT DELIVERY SYSTEM FROM THE GUIDEWIRE. THE STENT DELIVERY STENT DELIVERY SYSTEM AND GUIDEWIRE WERE ULTIMATELY REMOVED FROM THE PATIENT AS A UNIT, AND IN ONE PIECE. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543416 ↗
• MalfunctionApr 23, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT THE GUIDEWIRE WAS DIFFICULT TO REMOVE. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A .018/260 CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE DURING THE PROCEDURE. WHILE OPERATING WITHIN A HEAVILY OCCLUDED VESSEL, THE SURGEON ATTEMPTED TO WITHDRAW THE GUIDEWIRE. DURING THIS PROCESS, THE WIRE UNCOILED INSIDE THE PATIENT. NOTABLY, THERE WAS NO HARM TO THE PATIENT, AND THE GUIDEWIRE REMAINED INTACT DESPITE THE UNCOILING. THE DEVICE WAS REMOVED BY PULLING EVEN AFTER IT UNCOILED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890868 ↗
• MalfunctionMar 21, 2025Unraveled 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 25FEB2025. IT WAS REPORTED THAT GUIDEWIRE UNRAVELED OCCURRED. THE TARGET LESION WAS LOCATED IN A PERIPHERAL ARTERY. A PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN A LOWER EXTREMITY ANGIOGRAM. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE BECAME UNRAVELED AT THE DISTAL TIP. THE CORE WIRE REMAINED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DISTAL TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662316 ↗
• InjuryFeb 18, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE SEPARATED FROM OTHER DEVICES. A .018/260CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN WAS UNABLE TO SEPARATE THE SHEATH, WIRE, AND A NON-BOSTON SCIENTIFIC (BSC) SENSOR FROM EACH OTHER. THE WIRE DID NOT HAVE THE SUPPORT TO BRING THE SENSOR FORWARD TO THE PULMONARY ARTERY, SO THE PHYSICIAN TRIED TO PULL THE DEVICE BACK THROUGH THE SHEATH. THE SHEATH FOLDED OVER ON ITSELF. THE PHYSICIAN DETERMINED THEY COULD NOT SAFELY REMOVE THE SHEATH OR THE SENSOR, SO THE SITE'S VASCULAR SURGERY CAME TO ASSIST. VASCULAR TEAM WAS ABLE TO PULL THE SHEATH OUT, BUT THE SENSOR REMAINED IN THE PATIENT'S SOFT TISSUE. A SMALL CUT WAS PERFORMED WHICH ALLOWED THE SENSOR TO BE REMOVED. PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE, AND THE PATIENT WAS DISCHARGED AND NOT HOSPITALIZED FOLLOWING THE PROCEDURE. THERE WERE NO POST-PROCEDURE COMPLICATIONS, BUT THE PHYSICIAN REPORTED THERE TO BE A SIGNIFICANT DELAY DUE TO DECIDING THE PLAN OF ACTION AND WAITING FOR THE VASCULAR TEAM TO ARRIVE. IT WAS FURTHER REPORTED THAT THIS COMPLIANT WAS REPORTED VIA MEDWATCH NUMBER MW5165238.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395766 ↗
• MalfunctionNov 21, 2024Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TIP BREAK OCCURRED. A PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT CRITICAL LIMB ISCHEMIA. DURING THE PROCEDURE, APPROXIMATELY 1 CM OF THE TIP OF THE GUIDEWIRE SPLIT OR BROKE OFF. THE FINE SPIRAL THAT WAS WRAPPED AROUND THE TIP UNWOUND. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750325 ↗
• MalfunctionJun 20, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER ANKLE ARTERY. A 014/300/SST PLATINUM PLUS WAS SELECTED FOR USE. DURING ADVANCING, THE GUIDEWIRE WAS KINKED. THE GUIDEWIRE WAS PULLED BACK, AND IT LOOKED OKAY TO CONTINUING USING IT UNDER FLUOROSCOPY. UPON REMOVAL, IT WAS NOTED THAT THE GUIDEWIRE COULD NOT BE REMOVED. BOTH THE GUIDEWIRE AND THE NON-BOSTON SCIENTIFIC BALLOON WERE REMOVED. IT WAS NOTED THAT THE GUIDEWIRE WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576760 ↗
• MalfunctionApr 16, 2024Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS STRIPPED AND DEFORMED. THIS 0.018 IN X 260 CM PLATINUM PLUS GUIDEWIRE WAS REMOVED FROM ITS PACKAGING BUT WAS UNABLE TO BE USED. IT WAS NOTED THAT THE DEVICE WAS STRIPPED AND DEFORMED. A SECOND DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122187 ↗
• MalfunctionJun 9, 2023Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17MAY2023. IT WAS REPORTED THAT GUIDEWIRE UNRAVELED OCCURRED. THE PATIENT PRESENTED WITH HEART FAILURE. DURING AN INSERTION PROCEDURE OF A NON-BOSTON SCIENTIFIC DEVICE, FIVE 3 018/260 PLATINUM PLUS GUIDEWIRES WERE USED. HOWEVER, THE WIRES WERE UNRAVELED UPON INSERTION. VENOGRAM WAS PERFORMED TO MAKE SURE THAT THERE WAS NO STENOSIS THAT THE WIRES WERE GETTING STUCK IN. THE APPROXIMATE LOCATION OF THE DAMAGE ON THE DEVICE WAS THROUGH THE RIGHT INTERNAL JUGULAR. ALL THE GUIDEWIRES WERE REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED GUIDE WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100984 ↗
• MalfunctionMar 21, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH HEART FAILURE. DURING AN INSERTION PROCEDURE OF A NON-BOSTON SCIENTIFIC DEVICE, FIVE 3 018/260 PLATINUM PLUS GUIDEWIRES WERE USED. HOWEVER, THE WIRES WERE UNRAVELED UPON INSERTION. VENOGRAM WAS PERFORMED TO MAKE SURE THAT THERE WAS NO STENOSIS THAT THE WIRES WERE GETTING STUCK IN. THE APPROXIMATE LOCATION OF THE DAMAGE ON THE DEVICE WAS THROUGH THE RIGHT INTERNAL JUGULAR. THE PHYSICIAN HAD TO REMOVE THE SHEATH AND WIRE TOGETHER AT ONE POINT JUST TO REMOVE A GUIDEWIRE. ALL THE GUIDEWIRES WERE REMOVED INTACT, AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587825 ↗
• MalfunctionFeb 27, 2023Unraveled Material; Detachment of Device or Device Component; Difficult to Advance; Unraveled Material; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED. A 018/260 PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN A NON-BOSTON SCIENTIFIC CARDIOMEMS PROCEDURE. DURING THE PROCEDURE INSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDEWIRE COULD NOT BE ADVANCED, SO IT WAS WITHDRAWN. UPON REMOVAL, THE GUIDEWIRE WAS DISCOVERED TO BE UNRAVELED, FRAYED, AND SEPARATED AT THE TIP. THE PROCEDURE PROCEEDED WITH A V-18 GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449145 ↗
• MalfunctionFeb 6, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 014/300 PLATINUM PLUS GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING REMOVAL, THE GUIDEWIRE COULD NOT BE REMOVED FROM THE NON-BSC MICROCATHETER. UPON FURTHER REVIEW, IT WAS NOTICED THAT THE WIRE WAS STRETCHED AND BECAME UNRAVELED. EVERYTHING WAS REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303329 ↗
• InjuryJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF LESS THAN 45 DEGREES WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED THORACIC DUCT. A 3 018/260 PLATINUM PLUS GUIDEWIRE WAS USED DURING PROCEDURE. HOWEVER, WHILE REMOVING THE GUIDEWIRE FROM THE PATIENT THROUGH THE 21-GAUGE NEEDLE, THE TIP OF THE GUIDEWIRE SHEARED OFF INTO THE PATIENT'S THORACIC DUCT. A SNARE WAS USED TO REMOVE THE DETACHED DEVICE, AND NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16259462 ↗
• MalfunctionJan 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 018/260 PLATINUM PLUS GUIDEWIRE WAS USED FOR PERIPHERAL PROCEDURE. HOWEVER, WHEN THE DEVICE WAS PULLED, THE END OF THE WIRE BROKE OFF. THE DEVICE WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163864 ↗
• InjuryJan 4, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND UNRETRIEVABLE DEVICE FRAGMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS CROSSED THE HEAVILY CALCIFIED LESION AND BALLOONED IT. UPON REMOVAL OF THE DEVICE, THE GUIDEWIRE STRETCHED AND EVENTUALLY THE DISTAL END OF THE GUIDEWIRE BROKE OFF IN THE PATIENT. SNARING WAS ATTEMPTED BUT FAILED. THUS, THE PHYSICIAN DECIDED TO LEAVE IT BEHIND. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16099591 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports