Starter™ Guidewire M001491651Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729326779), received between Mar 2, 2021 and Nov 26, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2021Material Separation

  MID 40¿S MALE WITH PAST HISTORY OF COVID AND RECENT CHEST PAIN. PROCEDURE: LEFT CARDIAC CATH AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE BOSTON SCIENTIFIC STARTER GUIDEWIRE DEVELOPED A RINGLET THAT PEELED BACK JUST DISTAL FROM THE J TIP. IT WAS REMOVED WITHOUT KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877728 ↗
• MalfunctionJun 28, 2021Fracture; Fracture

  PER SALESFORCE COMPLAINT ID: (B)(4), IT WAS REPORTED THAT: TIME OF EVENT: DURING PREPARATION PROCEDURE INFORMATION PROCEDURE DATE: ASKED, BUT NOT AVAILABLE AS PER ACCOUNT/CUSTOMER. PROCEDURE TYPE: UNKNOWN WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: UNKNOWN WHAT WAS THE OUTCOME OF THE PROCEDURE?: UNKNOWN CLINICAL STUDY INFORMATION RELATED TO A CLINICAL STUDY?: NO DESCRIPTION OF THE EVENT DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) DESCRIPTION OF THE EVENT: CORRECT UPN M001491380. ACCOUNT REQUESTED TO RETURN FOR CREDIT: (4) BOX OF SAME LOT NUMBER. WHAT TROUBLESHOOTING STEPS TOOK PLACE? NA WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? USED DIFFERENT WIRE PRODUCTS PRODUCT? STARTER GUIDEWIRE, 0.035"/180CM/J3 UPN: 8749212 LOT/SERIAL NUMBER: (B)(6) WAS THE DEVICE IMPLANTED OR DID AN ATTEMPT TO IMPLANT OCCUR?: NO FAILURE MODES RELATED TO THIS DEVICE INCLUDE: BREAK/FRACTURED WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO INDICATE ANY ATTACHED/RELATED DEVICE(S): THE ACCOUNT HAS REQUESTED TO RETURN FOR CREDIT (4) BOXES OF THIS LOT NUMBER. GFE QUESTIONS [STARTER GUIDEWIRE, 0.035"/180CM/J3] WHAT IS THE PLAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12074275 ↗
• MalfunctionMar 28, 2021Fracture; Fracture

  EVENT DESCRIPTION: PER MEDWATCH, IT WAS REPORTED THAT: DESCRIBE THE EVENT OR PROBLEM OR PROBLEM: ELDERLY MALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. PROCEDURE IS PERCUTANEOUS INTERVENTION-BALLOON ANGIOPLASTY WITH STENT PLACEMENT. WHEN THE PACKAGE OF THE BSC GUIDEWIRE WAS OPENED, THE J WIRE WAS BROKEN/BENT. NOT USED ON PATIENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PERCUTANEOUS INTERVENTION - BALLOON ANGIOPLASTY WITH STENT PLACEMENT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580230 ↗
• MalfunctionMar 2, 2021Break; Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. PROCEDURE IS PERCUTANEOUS INTERVENTION-BALLOON ANGIOPLASTY WITH STENT PLACEMENT. WHEN THE PACKAGE OF THE BOSTON SCIENTIFIC GUIDEWIRE WAS OPENED, THE J WIRE WAS BROKEN/BENT. NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398606 ↗