ChoICE PTRecalls & reported problems across all models

We found 6 models of ChoICE PT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2019 and Jul 30, 2025 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 ChoICE PT problems

ChoICE PT models

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

• ChoICE™ PT H74912155011

  WIRE, GUIDE, CATHETER
  7 reports
• ChoICE™ PT H7491216101J1

  WIRE, GUIDE, CATHETER
  6 reports
• ChoICE™ PT H7491215501J1

  WIRE, GUIDE, CATHETER
  4 reports
• ChoICE™ PT H74912161011

  WIRE, GUIDE, CATHETER
  4 reports
• ChoICE™ PT H74912154011

  WIRE, GUIDE, CATHETER
  2 reports
• ChoICE™ PT H74912160011

  WIRE, GUIDE, CATHETER
  1 report

Recent ChoICE PT adverse event reports

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

• MalfunctionJul 30, 2025Entrapment of Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A CHOICE PT GUIDEWIRE WAS SELECTED FOR USE ALONG WITH A CAROTID WALLSTENT. THE STENT WAS SUCCESSFULLY DEPLOYED. WHEN THE USER ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM FROM THE PATIENT, THE DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED AS ONE UNIT, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668545 ↗
• InjuryJul 22, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT AND UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS LOCATED IN THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. UNKNOWN STENTS WERE DELIVERED TO THE MID-LAD AND DIAGONAL 2. DURING THE ATTEMPT TO RE-WIRE THE DIAGONAL 2 WITH A 182CM CHOICE GUIDEWIRE, THE GUIDEWIRE BECAME WEDGED UNDER A STENT AND COULD NOT BE WITHDRAWN. AN UNKNOWN BALLOON CATHETER WAS THEN ADVANCED IN AN ATTEMPT TO REMOVE THE WIRE SUCCESSFULLY. THE TIP OF THE GUIDEWIRE BROKE OFF AND REMAINED IN THE DIAGONAL 2 WITH SOME OF IT IN THE MID-LAD. FLOW WAS PRESERVED AT TIMI-3 GRADE, AND THE PATIENT REMAINED ASYMPTOMATIC. NO FURTHER ISSUES WERE REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22572171 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 300 PT ES CHOICE PT GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE ENTIRE TIP BROKE OFF AND REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21606405 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT THE TIP BECAME CRACKED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING ARTERY. A WOLVERINE CUTTING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AT THE END OF THE PROCEDURE, THE CUTTING BALLOON CATHETER WAS DIFFICULT TO REMOVE AND BECAME STUCK. THE BALLOON WAS EVENTUALLY REMOVED ALONG WITH THE ENTIRE SYSTEM. BOTH A 182 CM J CHOICE GUIDEWIRE AND ANOTHER UNSPECIFIED INTERVENTIONAL GUIDEWIRE WERE REMOVED WITH THE BALLOON AND BOTH WIRES WERE NOTED TO BE BENT AND CRACKED AT THE DISTAL TIP SO THAT THEY WERE ONLY PARTIALLY INTACT. THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577946 ↗
• InjurySep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT GUIDEWIRE DISTAL TIP DETACHMENT AND A DEVICE FRAGMENT REMAINED IN THE PATIENT. A 182CM CHOICE PT GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE IMPLANTATION OF THE PACEMAKER, THE DISTAL TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. A SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL LEAVING THE TIP OF THE WIRE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20311153 ↗
• InjuryJul 29, 2024Detachment 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 PATIENT PRESENTED FOR A PACEMAKER IMPLANT. A 182 CM J CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN PIECE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED, BUT THE TIP OF THE WIRE REMAINS IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19855987 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND ALMOST DETACHED FROM THE SHAFT AND THE GUIDEWIRES WERE PARTIALLY DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED FOR MULTIPLE INFLATIONS AT 14 TO 16 ATM FOR 12 TO 14 SECONDS. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL, THE WOLVERINE BALLOON WOULD NOT COME BACK THROUGH THE CHOICE PT FLOPPY GUIDEWIRE UPON DEFLATION. THE PHYSICIAN TRIED TO PULL DOUBLE NEGATIVE AND TOOK AN EMPTY 20CC SYRINGE AND PULLED NEGATIVE. NEITHER OF THESE TECHNIQUES WORKED. THE PHYSICIAN THEN INFLATED THE WOLVERINE TO 2 ATM AND DEFLATED BUT IT STILL WOULD NOT COME THROUGH TO THE GUIDEWIRE. THE PHYSICIAN THEN PLACED ANOTHER CHOICE PT FLOPPY GUIDEWIRE NEXT TO THE WOLVERINE WITH A 2.5MMX 12MM EMERGE BALLOON CATHETER ONTO THE WIRE. PHYSICIAN INFLATED NEXT TO THE WOLVERINE AND WAS FINALLY ABLE TO NUDGE THE BALLOON ENOUGH TO FULLY RETRACT IT OUT OF THE BODY. PHYSICIAN SAID IT WAS STILL VERY DIFFICULT TO RETRACT. UPON INVESTIGATION, IT WAS NOTED THAT THE TWO WIRES WERE BOTH FRAYED AND PARTIALLY DETACHED AND THE WOLVERINE SEEMED TO ALMOST BE DETACHED FROM THE SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619115 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND ALMOST DETACHED FROM THE SHAFT AND THE GUIDEWIRES WERE PARTIALLY DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED FOR MULTIPLE INFLATIONS AT 14 TO 16 ATM FOR 12 TO 14 SECONDS. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL, THE WOLVERINE BALLOON WOULD NOT COME BACK THROUGH THE CHOICE PT FLOPPY GUIDEWIRE UPON DEFLATION. THE PHYSICIAN TRIED TO PULL DOUBLE NEGATIVE AND TOOK AN EMPTY 20CC SYRINGE AND PULLED NEGATIVE. NEITHER OF THESE TECHNIQUES WORKED. THE PHYSICIAN THEN INFLATED THE WOLVERINE TO 2 ATM AND DEFLATED BUT IT STILL WOULD NOT COME THROUGH TO THE GUIDEWIRE. THE PHYSICIAN THEN PLACED ANOTHER CHOICE PT FLOPPY GUIDEWIRE NEXT TO THE WOLVERINE WITH A 2.5MMX 12MM EMERGE BALLOON CATHETER ONTO THE WIRE. PHYSICIAN INFLATED NEXT TO THE WOLVERINE AND WAS FINALLY ABLE TO NUDGE THE BALLOON ENOUGH TO FULLY RETRACT IT OUT OF THE BODY. PHYSICIAN SAID IT WAS STILL VERY DIFFICULT TO RETRACT. UPON INVESTIGATION, IT WAS NOTED THAT THE TWO WIRES WERE BOTH FRAYED AND PARTIALLY DETACHED AND THE WOLVERINE SEEMED TO ALMOST BE DETACHED FROM THE SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618737 ↗
• MalfunctionJun 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING WAS PEELING. A 182 CM CHOICE GUIDEWIRE WAS SELECTED FOR USE. DURING UNPACKING OF THE DEVICE, IT WAS NOTED THAT THE WIRE COATING WAS PEELING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578553 ↗
• InjuryJul 24, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 182 CM CHOICE PT GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, UPON PUTTING THE GUIDEWIRE DOWN THE VESSEL, IT BECAME STUCK. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE BUT UPON PULLING THE GUIDEWIRE OUT OF THE GUIDE, IT BROKE, AND THE UNCOILED TIP OF THE GUIDEWIRE WAS LEFT IN THE PATIENT. A SNARE WAS USED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE GUIDEWIRE FRAGMENT. THE PATIENT WAS SENT TO SURGERY TO RETRIEVE THE GUIDEWIRE TIP AND HAVE CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376232 ↗
• InjuryFeb 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT (B)(4) THAT GUIDEWIRE DISTAL TIP DETACHMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR ANGIOGRAM IN RIGHT LOWER EXTREMITY. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE TIP OF AN ANGIOGRAM WIRE DETACHED IN PATIENT'S LOWER LEG ARTERY. ANOTHER 300 PT ES (5PK) CHOICE WIRE WAS SELECTED FOR USE; HOWEVER, THE TIP OF WIRE ALSO DETACHED IN PATIENT'S LOWER LEG ARTERY. A MICROCATHETER GOOSENECK WAS ADVANCE TO SNARE DOWN THE ANTERIOR TIBIAL ARTERY BUT COULD NOT GET IT PASSED THE PROXIMAL PORTION OF THE ARTERY DUE TO THE HIGH DEGREE OF CALCIFICATION. IN ADDITION, THE V-18 WIRE WAS DISTALLY ADVANCE INTO THE ANTERIOR TIBIAL ARTERY WAS ABLE TO GET THE TIP OF THIS WIRE TO COIL UP AND WAS PULLED BACK THROUGH THE DETACHED CHOICE WIRE AND CAPTURE IT BACK TO THE SHEATH ABOVE THE KNEE POPLITEAL ARTERY. A MICRO CATHETER GOOSENECK SNARE WAS USED INTO THE SHEATH AND WAS ABLE TO RETRIEVE THE DISTAL TIP OF THE CHOICE PT WIRE. BOTH DEVICES WERE RETRIEVED AND REMOVED. A SIGNIFICANT CALCIFICATION IN THE ARTERY MAY HAVE CONTRIBUTED TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409468 ↗
• InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT TIP DETACHMENT OCCURRED. A CHOICE GUIDEWIRE WAS SELECTED FOR USE IN A CORONARY INTERVENTION PROCEDURE FOR A LESION IN THE LEFT MAIN. THE CHOICE GUIDEWIRE TIP SEPARATED WITHIN THE CORONARY ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED TIP BUT WERE UNSUCCESSFUL. THE INTERVENTIONAL CARDIOLOGIST DETERMINED THAT THE DETACHED TIP COULD REMAIN WITHIN THE CORONARY VESSEL WITHOUT IT CAUSING HARM TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15970771 ↗
• MalfunctionDec 9, 2022Break; Entrapment of Device

  THE INTERVENTIONAL WIRE IN THE PATIENT'S CORONARY ARTERY CAME APART AT THE RADIOPAQUE TO NON-RADIOPAQUE SECTION AND DOCTOR TRIED TO USE A SECOND WIRE TO LASSO THE WIRE, BUT UNSUCCESSFUL. DOCTOR REACHED OUT TO ANOTHER INTERVENTIONAL CARDIOLOGIST (DR. (B)(6)), AND DR. (B)(6) FELT AS IF NO ILL EFFECTS WOULD COME FROM JUST LEAVING THE WIRE TIP IN THE VESSEL. UPON CASE COMPLETION, DR. (B)(6) SPOKE WITH THE PATIENT REGARDING RESULTS AND THE WIRE TIP LEFT IN HIM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15949616 ↗
• InjuryOct 13, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN A SUPERFICIAL FEMORAL ARTERY. A 300CM (5PK) CHOICE PT GUIDEWIRE WAS INSERTED TO THE TARGET LESION. HOWEVER, DURING PROCEDURE, THE GUIDEWIRE BECAME LODGED BEHIND THE STENT THAT WAS PREVIOUSLY PLACED. WHEN THE GUIDEWIRE WAS REMOVED, THE DISTAL PART APPROXIMATELY 10 CM BROKE OFF AND REMAINED IN THE VESSEL. THE PHYSICIAN TRIED TO SNARE THE DETACHED COMPONENT BUT WAS UNSUCCESSFUL. THE TIP WAS LEFT INSIDE THE PATIENT'S BODY AND THE PHYSICIAN DECIDED TO STOP. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15601130 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. A 300 PT ES J CHOICE PT GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP AREA OF THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544967 ↗

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