Platinum Plus™ M001467320Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729326212), received between Aug 13, 2020 and Apr 23, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 13, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT ANGIOGRAM. THE CHRONICALLY TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED DISTAL ANTERIOR TIBIAL ARTERY. A 018/260CM PLATINUM PLUS GUIDEWIRE WAS ADVANCED. UPON CROSSING THE LESION, THE GUIDEWIRE PROLAPSED INTO A KNOT AND COULD NOT BE REMOVED THROUGH THE 018 STERLING BALLOON CATHETER OR THE 035 RUBICON GUIDE CATHETER. THE GUIDEWIRE WAS REMOVED INTACT WITH THE GUIDE CATHETER. HOWEVER, DURING WITHDRAWAL, THE GUIDEWIRE TIP COMPLETELY UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A 014 SAVION GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974516 ↗
• InjurySep 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 018/260 PLATINUM PLUS GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, IT WAS OBSERVED THAT THE WIRE AND AN AXILLARY BALLOON PUMP WERE SEPARATED INSIDE THE PATIENT'S BODY. THE PHYSICIAN HAD TO GAIN FEMORAL ACCESS AND SNARED THE DISTAL PORTION OF THE WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480486 ↗
• InjurySep 14, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND UN-RETRIEVED DEVICE FRAGMENT OCCURRED. DURING A CARDIOMEMS IMPLANT PROCEDURE, A 018/260CM PLATINUM PLUS GUIDEWIRE WAS USED AND POSITIONED. HOWEVER, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS POINTING BACK DOWN THE LENGTH OF THE WIRE RATHER THAN DOWN THE ARTERIAL BRANCH. WHEN THE GUIDEWIRE WAS PULLED BACK INTO THE CARDIOMEMS DELIVERY CATHETER THE DISTAL 3CM OF THE GUIDEWIRE SHEARED OFF AND REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. HEPARIN WAS ADMINISTERED AND THE PATIENT WAS RETAINED OVERNIGHT FOR OBSERVATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15421892 ↗
• InjurySep 14, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND UN-RETRIEVED DEVICE FRAGMENT OCCURRED. DURING A CARDIOMEMS IMPLANT PROCEDURE, A 018/260CM PLATINUM PLUS GUIDEWIRE WAS USED AND POSITIONED. HOWEVER, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS POINTING BACK DOWN THE LENGTH OF THE WIRE RATHER THAN DOWN THE ARTERIAL BRANCH. WHEN THE GUIDEWIRE WAS PULLED BACK INTO THE CARDIOMEMS DELIVERY CATHETER THE DISTAL 3CM OF THE GUIDEWIRE SHEARED OFF AND REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. HEPARIN WAS ADMINISTERED AND THE PATIENT WAS RETAINED OVERNIGHT FOR OBSERVATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421846 ↗
• InjurySep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A .018/260CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE REMOVAL OF CARDIOMEMS IMPLANT SHEATH, THE PROXIMAL TIP OF THE WIRE BROKE OFF AND WAS LEFT IN THE PULMONARY ARTERY. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE DETACHED WIRE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15418649 ↗
• MalfunctionJul 14, 2022Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24-JUN-2022. IT WAS REPORTED THAT GUIDEWIRE UNRAVELED OCCURRED. THE TARGET LESION WAS LOCATED IN PULMONARY ARTERY. A 018/260CM PLATINUM PLUS GUIDEWIRE WAS ADVANCED; HOWEVER, DURING THE PROCEDURE, THE WIRE UNRAVELED AT THE TIP. THE WIRE WAS PULLED OUT OF THE SHEATH IN ONE PIECE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15015247 ↗
• MalfunctionMay 31, 2022Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A .018/260CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE DEVICE ARRIVED WITH INNER SEAL COMPROMISED, PACKAGING WAS DAMAGED, AND THE BOX WAS CRUMBLED AND LOOKED LIKE A DRIED CARDBOARD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552554 ↗
• MalfunctionMay 31, 2022Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A .018/260CM PLATINUM PLUS GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE DEVICE ARRIVED WITH INNER SEAL COMPROMISED, PACKAGING WAS DAMAGED, AND THE BOX WAS CRUMBLED AND LOOKED LIKE A DRIED CARDBOARD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552517 ↗
• InjuryAug 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING INTERVENTION. A .018/260CM PLATINUM PLUS - PI GUIDEWIRE WAS SELECTED FOR USE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). HOWEVER, THE WIRE TIP CAME OFF IN THE PATIENT'S BODY. THE PHYSICIAN GAINED A SECOND ACCESS SITE (LEFT PEDAL ARTERY) AND USED A BALLOON AND SNARE TECHNIQUE TO RETRIEVE THE WIRE TIP. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10402386 ↗