Platinum Plus™ M001467120Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729486886), received between Jan 11, 2019 and Jul 18, 2025 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• InjuryDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED AND REMAINED IN THE PATIENT. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP BROKE OFF INSIDE THE PATIENT AND THE BROKEN TIP WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15900861 ↗
• InjuryAug 16, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED AND THE DISTAL TIP DETACHED. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS ADVANCED IN THE NON-TORTUOUS, MILDLY CALCIFIED, PERONEAL ARTERY, FOR TREATMENT OF PERIPHERAL ARTERY DISEASE. ONCE THE GUIDEWIRE REACHED THE ARTERY THE PHYSICIAN NOTICED THE GUIDEWIRE WAS ELONGATING AND THE DISTAL TIP WAS NOT MOVING. IT WAS IDENTIFIED THAT THE GUIDEWIRE UNRAVELED AND THE DISTAL TIP DETACHED. A THRUWAY GUIDEWIRE WAS USED TO HELP ADVANCE THE PLATINUM GUIDEWIRE, BY WRAPPING IT AROUND THE DISTAL ASPECT OF THE WIRE. THEN IN THE PERONEAL ARTERY, A NON-BOSTON SCIENTIFIC DEVICE WAS USED TO RETRIEVE THE DISTAL TIP OF THE PLATINUM PLUS GUIDEWIRE. THE DEVICES WERE REMOVED AS A UNIT FROM THE PATIENT, WITH NO PATIENT COMPLICATIONS. THE CASE WAS SUCCESSFULLY COMPLETED WITH A THRUWAY 0.014 300CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233305 ↗
• MalfunctionAug 15, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED AND THE DISTAL TIP DETACHED. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS USED IN THE NON-TORTUOUS, MILDLY CALCIFIED SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES FOR IMAGING. DURING THE PROCEDURE, THE DOCTOR NOTICED THE GUIDEWIRE WAS UNRAVELING AND DECIDED TO REMOVE THE GUIDEWIRE, WITH THE IVUS DEVICE. AFTER REMOVING EVERYTHING, IT WAS NOTICED ON THE BACK TABLE, THAT THE DISTAL END OF THE GUIDEWIRE WAS DETACHED. THE DOCTOR FLUSHED THE CATHETER AND THE DETACHED TIP OF THE GUIDEWIRE, FLUSHED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229098 ↗
• InjuryAug 12, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED, AND THE TIP DETACHED. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS USED FOR TREATMENT OF PERIPHERAL ARTERY DISEASE IN THE TIBIAL ARTERY. THE ANATOMY WAS NOT TORTUOUS AND THERE WAS LITTLE TO NO CALCIUM. THE DOCTOR WAS ATTEMPTING TO WIRE THE ARTERY WITH THE FIRST PLATINUM PLUS GUIDEWIRE AND NOTICED THE GUIDEWIRE LOOKED FUNNY UNDER FLUOROSCOPY. IT WAS FOUND THAT THE TRANSITION WAS UNRAVELING. THE GUIDEWIRE WAS REMOVED COMPLETELY. THE DOCTOR THEN DECIDED TO USE A SECOND PLATINUM PLUS GUIDEWIRE. THIS GUIDEWIRE UNRAVELED AND THE DISTAL TIP DETACHED. THE DOCTOR USED A SNARE TO REMOVE THE DETACHED TIP FROM THE PATIENT. ALL GUIDEWIRE WAS REMOVED FROM PATIENT, LEAVING NOTHING BEHIND. A THRUWAY 0.014 WIRE WAS THEN USED TO COMPLETE THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15221441 ↗
• MalfunctionAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED. THE TARGET LESION WAS 90% STENOSED WITH NORMAL TORTUOSITY AND VERY STRONG CALCIFICATION. THE TARGET LESION WAS LOCATED IN THE FIBULAR ARTERY. A PLATINUM PLUS PI GUIDEWIRE AND JET STREAM CATHETER WERE SELECTED FOR USE. DURING WITHDRAWAL OF THE PLATINUM PLUS PI GUIDEWIRE, THE TIP DETACHED. THE TIP WAS RETRIEVED BY CATHETERIZATION USING A 0.018 GUIDEWIRE. THERE WERE NO FURTHER PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210990 ↗
• InjuryAug 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA UP-AND-OVER TECHNIQUE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 014/300/SST PLATINUM PLUS GUIDEWIRE AND A NON-BOSTON SCIENTIFIC (BSC) SUPPORT CATHETER WERE ADVANCED INTO THE LESION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE TIP FRACTURED. THE DETACHED FRAGMENT WAS RETRIEVED BY SNARING AND ARTERIAL EXPLORATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188065 ↗
• MalfunctionNov 8, 2021Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE LOWER LEG. A 014/300/SST PLATINUM PLUS - PI GUIDEWIRE WAS ADVANCED. A 3.0MM X 60MM X 150CM, OTW COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATION. AT SOME POINT DURING THE PROCEDURE, THE TIP OF THE 014/300/SST PLATINUM PLUS - PI GUIDEWIRE UNRAVELED. WHILE ATTEMPTING TO REMOVE THE 3.0MM X 60MM X 150CM, OTW COYOTE BALLOON CATHETER AT THE END OF THE PROCEDURE, THE COYOTE BALLOON CATHETER AND PLATINUM PLUS PI GUIDEWIRE COULD NOT BE SEPARATED AND WERE REMOVED TOGETHER FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771733 ↗
• MalfunctionMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-APR-2021. IT WAS REPORTED THAT NO INFORMATION WAS AVAILABLE REGARDING THE EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SPRING TIP WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 11843355 ↗
• InjuryMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE CAME OFF AND WAS LODGED IN THE ANTERIOR TIBIAL ARTERY. A 0.014 INCH, 300CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE IN AN ANGIOPLASTY PROCEDURE OF THE ANTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED AND BECAME LODGED IN THE ANTERIOR TIBIAL ARTERY. THE PROCEDURE WAS STOPPED. THE PATIENT CAME TO NO HARM AND WAS STABLE. AT THIS TIME, THE PHYSICIAN DOES NOT FEEL THAT THE PATIENT WOULD BENEFIT FROM AN OPERATION TO REMOVE THE TIP. THE TIP IS IN THE OCCLUDED PORTION OF THE ARTERY AND IS NOT LIKELY TO MIGRATE OR CAUSE ANY ISSUES IN MRI. IT WAS FURTHER REPORTED THAT THE LESION WAS TOTALLY OCCLUDED WITH A MIXTURE OF PLAQUE AND CALCIUM. THE LESION WAS IN A STRAIGHT VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 11496542 ↗
• MalfunctionDec 2, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY (PT). A 2.5MM X 150MM X 150CM COYOTE BALLOON CATHETER AND A 014/300/SST PLATINUM PLUS GUIDEWIRE WERE ADVANCED FOR USE. HOWEVER, DURING PROCEDURE, THE BALLOON COULD NOT BE ADVANCED TO THE DISTAL PT. WHEN THE BALLOON WAS PULLED BACK, IT DID NOT CAME OUT AND WAS STUCK ON THE WIRE. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, IT WAS ALSO UNABLE TO BE WITHDRAWN. THE BALLOON AND THE WIRE WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH THE SAME SIZE COYOTE BALLOON CATHETER AND A V-14 CONTROLWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395545 ↗
• InjuryOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE RIGHT ARM. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, THE FRAYED TIP BROKE OFF IN THE RIGHT BRACHIAL ARTERY. THE BROKEN PORTION WAS NOT RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS NORMAL. IT WAS FURTHER REPORTED VIA FACILITY MAUDE REPORT MW5090039 THAT THE BROKEN TIP WAS LODGED EXTRAMURAL TO BRACHIAL ARTERY AND SO THE PHYSICIAN DECIDED TO LEAVE IT THERE AS IT WOULD CAUSE MORE HARM THAN GOOD TO REMOVE THE TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9175295 ↗
• MalfunctionSep 25, 2019Break; Material Frayed

  PT UNDERWENT RIGHT BRACHIAL ANGIOPLASTY, RIGHT RADIAL ARTERY ANGIOPLASTY, RIGHT ULNAR ARTERY ANGIOPLASTY. TIP OF A PLATINUM PLUS GUIDEWIRE .014 X 300 CM FRAYED AND BROKE OFF. TIP IS EXTRAMURAL TO BRACHIAL ARTERY SO IT WILL REMAIN THERE PER DR (B)(6). DR (B)(6) ALSO STATED IT WOULD CAUSE MORE HARM THAN GOOD TO REMOVE TIP 2/2 PT'S HEALTH STATUS. PROCEDURE WOULD BE AN OPEN ARM SURGICAL PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9123885 ↗
• MalfunctionJul 25, 2019Stretched; Material Deformation; Material Integrity Problem; Stretched; Material Deformation; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-JUL-2019. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE TIP WAS DAMAGED, BENT, STRETCHED, AND ELONGATED WHEN REMOVED FROM THE SHEATH. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE DISTAL TIP WAS DETACHED.

  Patient problems: No Patient Involvement

  MAUDE report 8826708 ↗
• InjuryJul 16, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 014/300/SST PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL, THE TIP OF THE WIRE BROKE OFF. THE PIECE OF THE WIRE WAS THEN REMOVED USING A GOOSENECK SNARE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794580 ↗
• InjuryJan 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A PLATINUM PLUS WAS INSERTED TO THE TARGET LESION. HOWEVER DURING PROCEDURE, IT WAS NOTED THAT THE DISTAL PORTION OF WIRE SEPARATED INSIDE THE PATIENT'S BODY. PATIENT INJURY OCCURRED AND THE PHYSICIAN REMOVED THE DEVICE AFTER WHICH THE PATIENT WAS FINE.

  Patient problems: Injury

  MAUDE report 8240205 ↗