ChoICE™ PT H74912155011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729303039), received between Dec 16, 2020 and Mar 14, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. THE TARGET LESION WAS COMPLETELY OCCLUDED, SEVERELY CALCIFIED AND MILDLY TORTUOUS AND WAS LOCATED IN THE FOOT ARTERIES. THERE WAS NO REPORTED ISSUE WITH THIS CHOICE PT GUIDEWIRE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522288 ↗
• MalfunctionMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAY2022. THE TARGET LESION WAS COMPLETELY OCCLUDED, SEVERELY CALCIFIED AND MILDLY TORTUOUS AND WAS LOCATED IN THE FOOT ARTERIES. THERE WAS NO REPORTED ISSUE WITH THIS CHOICE PT GUIDEWIRE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470991 ↗
• MalfunctionMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-MAY-2022. THE TARGET LESION WAS COMPLETELY OCCLUDED, SEVERELY CALCIFIED AND MILDLY TORTUOUS AND WAS LOCATED IN THE FOOT ARTERIES. THERE WAS NO REPORTED ISSUE WITH THIS CHOICE PT GUIDEWIRE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470789 ↗
• MalfunctionMay 18, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAY2022. IT WAS REPORTED THAT AN ACCIDENT RELATING TO THE DEVICE OCCURRED. A CHOICE PT GUIDEWIRE WAS SELECTED FOR USE. AN ACCIDENT OCCURRED RELATING TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. HOWEVER, DEVICE ANALYSIS REVEALED THE DISTAL TIP HAS A MISSING PORTION OF 1MM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429068 ↗
• MalfunctionDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED. A CHOICE PT WIRE WAS SELECTED FOR A CORONARY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PTA PROCEDURE, THE TIP DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS FURTHER REPORTED THAT A CHOICE PT WIRE WAS SELECTED FOR USE IN AN ARTERY BELOW-THE-KNEE (BTK). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11020952 ↗