ThreaderRecalls & reported problems across all models

We found 2 models of Threader by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2018 and Dec 31, 2025 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 Threader problems

Threader models

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

• Threader™ H7493926912120

  Catheters, transluminal coronary angioplasty, percutaneous
  27 reports
• Threader™ H7493927012120

  Catheters, transluminal coronary angioplasty, percutaneous
  17 reports

Recent Threader adverse event reports

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

• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 1.2MM X 12MM FG THREADER MONORAIL WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, THE BALLOON SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934345 ↗
• InjuryJun 9, 2025Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE WITHDRAWN, FRACTURED AND REMAINED INSIDE PATIENT. THE PATIENT PRESENTED WITH CHRONIC TOTAL OCCLUSION (CTO) AND UNDERWENT CORONARY PERCUTANEOUS CORONARY INTERVENTION STENT IMPLANTATION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE CTO WAS SUCCESSFULLY OPENED IN THE LAD, IT WAS FOUND THAT THE OPENING OF THE SEPTAL BRANCH WAS SEVERELY STENOSED. THE 1.2MM X 12MM FG THREADER MICRO DILATION BALLOON CATHETER WAS USED TO PRE-DILATE THE SEPTAL BRANCH. AFTER THE BALLOON WAS DILATED WITH A PRESSURE PUMP, IT WAS FOUND THAT IT COULD NOT BE WITHDRAWN OR ADVANCED FORWARD AND PULLED BACKWARD. THE PHYSICIAN THEN CUT THE DELIVERY SHAFT AND ADVANCED A GUIDEZILLA TO REMOVE IT. AFTER MULTIPLE ATTEMPTS TO REMOVE THE DEVICE, THE TIP OF THE CATHETER WAS FRACTURED. AN ATTEMPT WAS MADE TO GRASP THE DEVICE FRAGMENT BUT FAILED, AND A STENT WAS IMMEDIATELY IMPLANTED TO COVER THE FRACTURED TIP. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE THREADER CATHETER WAS USED FOR OPENING THE BLOOD VESSEL DURING

  Patient problems: Foreign Body In Patient

  MAUDE report 22171190 ↗
• MalfunctionJun 6, 2025Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON COULD NOT REACH THE LESION SITE, AND THE CATHETER WAS FOUND TO BE KINKED AFTER WITHDRAWN. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE SEGMENT OF LEFT ANTERIOR DESCENDING DIAGONAL BRANCH. A 1.2MM X 12MM FG THREADER MONORAIL WAS SELECTED FOR CORONARY ARTERY ANGIOGRAPHY (CAG) AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT REACH THE LESION SITE, AND THE CATHETER WAS FOUND TO BE KINKED AFTER WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE CIRCUMFERENTIAL TEAR IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161730 ↗
• MalfunctionApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). A 1.2MM X 12MM FG THREADER MR WAS SELECTED FOR PERCUTANEOUS CORONARY BALLOON DILATATION. AFTER THE BALLOON DILATED DURING PROCEDURE, THE BALLOON BURST IN THE PATIENT'S BODY UPON THIRD INFLATION AT 14ATM, AND THE PROCEDURE WAS SUSPENDED. THE BALLOON WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122699 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444027 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION AT NOMINAL PRESSURE, IT WAS NOTICED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435141 ↗
• MalfunctionJan 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE BALLOON BURST AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18430515 ↗
• MalfunctionAug 30, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND WAS TO UNDERGO PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE LESION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED, BUT IT ALSO FAILED TO PASS THE LESION AND DURING THIRD INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 1.5X12 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS PLACED TO TREAT THE LESION. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA WITH 95% STENOSIS. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING SECOND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DUE TO THE NATURE OF THE PROCEDURE, THE PATIENT WILL BE RETURNING FOR A ROTABLATOR PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653503 ↗
• MalfunctionAug 30, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND WAS TO UNDERGO PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE LESION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED, BUT IT ALSO FAILED TO PASS THE LESION AND DURING THIRD INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 1.5X12 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS PLACED TO TREAT THE LESION. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA WITH 95% STENOSIS. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING SECOND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DUE TO THE NATURE OF THE PROCEDURE, THE PATIENT WILL BE RETURNING FOR A ROTABLATOR PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653501 ↗
• MalfunctionApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS BY NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811097 ↗
• MalfunctionDec 5, 2022Component Missing; Component Missing

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT A DEVICE COMPONENT WAS MISSING. UPON UNPACKING OF A 1.2MM X 12MM THREADER BALLOON CATHETER, IT WAS NOTICED THAT THE BALLOON WAS MISSING. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914767 ↗
• MalfunctionNov 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED FIRST OBTUSE MARGINAL 1. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 1.2X12 THREADER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833461 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751416 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12645351 ↗
• MalfunctionOct 5, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT CROSSING DIFFICULTY LED TO PROCEDURE CANCELLATION OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576035 ↗

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