STARTER™ GUIDE M001491211Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729326540), received between Oct 14, 2020 and Dec 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionDec 8, 2025Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  RELATED PRODUCT MODEL #: 42255. RELATED PRODUCT SERIAL #: NO VALUE FOUND. RELATED PRODUCT UPN #: M001491211. RELATED PRODUCT BATCH/LOT: 0009895902. RELATED PRODUCT FAMILY: STARTER MATERIAL NUMBER: M001491211. STERILE LOT NUMBER: NO VALUE FOUND. SOLD TO ACCOUNT NUMBER: NO VALUE FOUND. RETURNED PRODUCT EXPECTED: NO. BSC PRODUCT RETURN DATE: NO VALUE FOUND. LOCATION DESCRIPTION: NO VALUE FOUND. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED, ORIGINAL DEVICE USED, PROCEDURE COMPLETED. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PHYSICIAN HAD PRIOR ISSUES WITH THE J-WIRE THAT CAME IN THE CATH PACK FOR WATCHMAN (UNFORTUNATELY, NO LOT NUMBER IS AVAILABLE) SO THEY DECIDED THAT TO OPEN A BOSTON SCIENTIFIC STARTER GUIDEWIRE (LOT # 9895902) AND THERE WAS RESISTANCE WHEN IT WAS IN THE DILATOR. BECAUSE THEY HAD INCREASED RESISTANCE, THEY REMOVED THAT AND OPENED AN AMPLATZ EXTRA STIFF GUIDEWIRE (LOT #16808605) AND HE STILL HAD INCREASED RESISTANCE AND SAID THAT IT ACTUALLY FELT LIKE A RACHET. HE WAS ABLE TO ADVANCE THE WIRE INTO THE SVC, ADVANCE THE DILATOR AND TRUSTEER, SWITCH OUT THE WIRE FOR THE PIGTAIL WIRE THAT COMES IN THE V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743074 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: CONTACTED BY THE LAB STATING THAT THEY HAD A COUPLE WIRES FROM THE SAME BOX THAT SEEMED TO START TO SEPARATE AND LOOSE ITS TIP AND CORE FUNCTIONALITY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? NA WHAT IS THE NEXT COURSE OF ACTION? INVESTIGATE DEVICE PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE. DATE-UNKNOWN. EVENT DATE: NO VALUE FOUND. AS REPORTED DEVICE CODES: 2446: UNRAVELED MATERIAL. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE, ATTEMPTED. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. AS REPORTED DEVICE CODES: 2446: UNRAVELED MATERIAL. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145592 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: CONTACTED BY THE LAB STATING THAT THEY HAD A COUPLE WIRES FROM THE SAME BOX THAT SEEMED TO START TO SEPARATE AND LOOSE ITS TIP AND CORE FUNCTIONALITY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? NA WHAT IS THE NEXT COURSE OF ACTION? INVESTIGATE DEVICE PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN EVENT DATE: NO VALUE FOUND AS REPORTED DEVICE CODES: 2446: UNRAVELED MATERIAL AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT AS REPORTED DEVICE CODES: 2446: UNRAVELED MATERIAL AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145379 ↗
• MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE - ATTEMPTED EVENT DESCRIPTION: 'THE INTER CORE WIRE IS COMING OUT OF THE BRAIDED PART OF THE CURVE AND CATCHING ON PLAQUE , TISSUE ECT. WHICH IS CAUSING ISSUES. - FROM ACCOUNT CONTACT PERSON WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USED ALTERNATE WIRE WHAT IS THE NEXT COURSE OF ACTION?: REPLACEMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN, EVENT DATE: NO VALUE FOUND, INITIAL REPORTER: YES, PERSON TYPE: PHYSICIAN, FACILITY/BUSINESS NAME: (B)(6), TITLE: DR., FIRST NAME: (B)(6), MIDDLE NAME: NO VALUE FOUND, LAST NAME: (B)(6), ADDRESS 1: (B)(6). ADDRESS 2: NO VALUE FOUND, CITY: (B)(6), STATE/PROVINCE: (B)(6), COUNTRY: UNITED STATES, ZIP/POSTAL CODE: (B)(6), PHONE: (B)(6), EMAIL: NO VALUE FOUND, FAX: NO VALUE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100639 ↗
• MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE. ATTEMPTED. EVENT DESCRIPTION: 'THE INTER CORE WIRE IS COMING OUT OF THE BRAIDED PART OF THE CURVE AND CATCHING ON PLAQUE , TISSUE, ECT. WHICH IS CAUSING ISSUES. - FROM ACCOUNT CONTACT PERSON. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USED ALTERNATE WIRE. WHAT IS THE NEXT COURSE OF ACTION?: REPLACEMENT PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE DATE-UNKNOWN. EVENT DATE: NO VALUE FOUND. INITIAL REPORTER: YES PERSON TYPE: PHYSICIAN FACILITY/BUSINESS NAME: (B)(6). MEDICAL CENTER. TITLE: DR. FIRST NAME: (B)(6). MIDDLE NAME: NO VALUE FOUND. LAST NAME: (B)(6). ADDRESS 1: (B)(6). ADDRESS 2: NO VALUE FOUND. CITY: (B)(6). STATE/PROVINCE: (B)(6). COUNTRY: (B)(6). ZIP/POSTAL CODE: (B)(6). PHONE: (B)(6). EMAIL: NO VALUE FOUND. FAX: NO VALUE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099818 ↗
• MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED, UNABLE TO USE DEVICE - ATTEMPTED EVENT DESCRIPTION: 'THE INTER CORE WIRE IS COMING OUT OF THE BRAIDED PART OF THE CURVE AND CATCHING ON PLAQUE , TISSUE ECT. WHICH IS CAUSING ISSUES. - FROM ACCOUNT CONTACT PERSON WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USED ALTERNATE WIRE WHAT IS THE NEXT COURSE OF ACTION?: REPLACEMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN. EVENT DATE: NO VALUE FOUND. INITIAL REPORTER: YES. PERSON TYPE: PHYSICIAN. FACILITY/BUSINESS NAME: (B)(6). TITLE: DR. FIRST NAME: (B)(6). MIDDLE NAME: NO VALUE FOUND. LAST NAME: (B)(6). ADDRESS 1: (B)(6). ADDRESS 2: NO VALUE FOUND. CITY: (B)(6). STATE/PROVINCE: (B)(6). COUNTRY: UNITED STATES. ZIP/POSTAL CODE: (B)(6). PHONE: (B)(6). EMAIL: NO VALUE FOUND. FAX: NO VALUE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099667 ↗
• MalfunctionNov 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE - ATTEMPTED EVENT DESCRIPTION: 'THE INTER CORE WIRE IS COMING OUT OF THE BRAIDED PART OF THE CURVE AND CATCHING ON PLAQUE , TISSUE ECT. WHICH IS CAUSING ISSUES. - FROM ACCOUNT CONTACT PERSON WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USED ALTERNATE WIRE WHAT IS THE NEXT COURSE OF ACTION?: REPLACEMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN, EVENT DATE: NO VALUE FOUND, INITIAL REPORTER: YES,. PERSON TYPE: PHYSICIAN., FACILITY/BUSINESS NAME: (B)(6), TITLE: DR., FIRST NAME: (B)(6) , MIDDLE NAME: NO VALUE FOUND., LAST NAME: (B)(6), ADDRESS 1: (B)(6), ADDRESS 2: NO VALUE FOUND, CITY: (B)(6), STATE/PROVINCE: (B)(6), COUNTRY: (B)(6), ZIP/POSTAL CODE: (B)(6), PHONE:(B)(6), EMAIL: NO VALUE FOUND, FAX: NO VALUE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099498 ↗
• MalfunctionNov 7, 2023Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED VIA ALTERNATIVE METHOD,UNABLE TO USE DEVICE - ATTEMPTED. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT EVENT DESCRIPTION: ECN EVENT DESCRIPTION: 'THE INTER CORE WIRE IS COMING OUT OF THE BRAIDED PART OF THE CURVE AND CATCHING ON PLAQUE , TISSUE ECT. WHICH IS CAUSING ISSUES. - FROM ACCOUNT CONTACT PERSON WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: USED ALTERNATE WIRE WHAT IS THE NEXT COURSE OF ACTION?: REPLACEMENT PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PROCEDURE DATE-UNKNOWN EVENT DATE: NO VALUE FOUND. AS REPORTED DEVICE CODES: 1103: COATING ISSUE, 1763: KINKED AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS PROCEDURE DATE: NO VALUE FOUND TYPE OF PROCEDURE: NO VALUE FOUND COUNTRY OF EVENT: UNITED STATES COUNTRY OF ORIGINAL IMPLANT USE: NO VALUE FOUND IMPLANT DATE: NO VALUE FOUND EXPLANT DATE: NO VALUE FOUND OOS DATE: NO VALUE FOUND. INITIAL REPORTER: YES. PERSON TYPE: DISTRIBUTOR. FACILITY/BUSINESS NAME: (B)(6) MEDICAL CENTER. TITLE: SUPPLY CHAIN FIRST NAME: (B)(6) MIDDLE NAME: NO VALUE FOUND LAST NAME:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082750 ↗
• MalfunctionDec 3, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT: DOSSIER: MV 21-0540 DIFFICULTY IN PROGRESSING WITH THE GUIDE IN THE HUMERAL ARTERY. WHEN IT IS RELEASED, THE SHEATH WAS SEVERED. CLINICAL CONSEQUENCES OBSERVED: SECOND SURGICAL APPROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923262 ↗
• MalfunctionFeb 21, 2021Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT: TORN GUIDE (ANOMALY DETECTED DURING USE). ADDITIONAL INFORMATION: 'THE SALE REP RESPONDED WITH THE FOLLOWING: 1. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? NO. 2. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? NO. 3. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? YES. 4. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? I DON'T KNOW. 5. WERE ANY PROBLEMS NOTED DURING PREPARATION? NO. 6. WAS UNUSUAL FORCE EVER REQUIRED WHEN USING THE DEVICE? NO. 7. THE LOT NUMBER PROVIDED 5926543 DOES NOT MATCH WITH THE GUIDE STARTER INVOLVED. COULD YOU PLEASE PROVIDE THE STARTER DEVICE BATCH/LOT #? 5926453. 8. THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. I WOULD LIKE TO CONFIRM IF THE DEVICE IS AVAILABLE FOR ANALYSIS? IF YES, WHAT IS THE EXPECTED DATE OF DEVICE TO BE RETURNED TO BSC? IF NO, WHAT IS REASON OF DEVICE NOT AVAILABLE FOR RETURN? DEVICE AVAILABLE AT THE PHARMACY SERVICE / CARRIER DID NOT SHOW UP [?]'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356662 ↗
• MalfunctionOct 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT: MERCED VASCULAR AND VEIN CENTER REACHED OUT TO BSC REPRESENTATIVE TODAY AND SAID THIS WIRES TIP FRAYED AND THE TIP FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10676609 ↗