Threader™ H7493926912120Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729848127), received between Aug 15, 2018 and Dec 31, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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, 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 25 most recent of 27 reports, 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  IT WAS REPORTED THAT THE CATHETER COULD NOT BE WITHDRAWN, FRACTURED AND REMAINED INSIDE PATIENT.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 AFTER THE BALLOON WAS DILATED WITH A PRESSURE PUMP, IT WAS FOUND THAT IT COULD NOT BE WITHDRAWN OR ADVANCED FORWARD AND PULLED BACKWARD.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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED VESSEL. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305458 ↗
• MalfunctionJan 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND NO HARM DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11206872 ↗
• MalfunctionDec 5, 2020Material 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 NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10954555 ↗
• MalfunctionSep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478444 ↗
• InjuryJul 1, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN THE ANATOMY. A 1.75MM ROTAPRO, 330CM ROTAWIRE, AND 1.2MM X 12MM THREADER WERE USED IN A PERCUTANEOUS CORONARY INTERVENTION IN THE MID RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE DEVICES BECAME STUCK IN THE MID RCA AND WERE UNABLE TO BE REMOVED FROM THE BODY. THE DEVICES WERE LEFT INSIDE THE BODY. IT WAS FURTHER REPORTED THAT A NON-BSC GUIDEWIRE ALSO BECAME ENTRAPPED DURING THIS PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10218895 ↗
• MalfunctionJan 17, 2020Material 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 PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601351 ↗
• MalfunctionAug 16, 2019Material 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 6 ATMOSPHERES, THE BALLOON RUPTURED. A NEW THREADER BALLOON CATHETER BALLOON WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901727 ↗
• MalfunctionJun 3, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663209 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT HUB DETACHMENT OCCURRED. THE TARGET LESION CONTAINED A 90 DEGREES BEND AND WAS LOCATED IN THE VERY TORTUOUS CIRCUMFLEX ARTERY (CX). THE PHYSICIAN HAD A DIFFICULT TIME WIRING THE VESSEL. A 1.2MMX12MM THREADER BALLOON CATHETER WAS PLACED TO GIVE SUPPORT IN WIRING THE 90 DEGREES BEND IN THE CX. THE DEVICE WAS IN THE BODY FOR APPROXIMATELY 20 TO 25 MINUTES. THE BALLOON WAS NEVER INFLATED AND WHEN THE DEVICE WAS REMOVED, THE SCRUB TECH WAS COILING THE HYPOTUBE IN WIDE LOOPS WHEN THE HUB SNAPPED CLEANLY OFF. THE DEVICE WAS COMPLETELY REMOVED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A SEPARATION 31.3CM FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483575 ↗
• MalfunctionMar 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR USE FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS 100% STENOSED. THE BALLOON WAS UNABLE TO CROSS THE LESION AREA COMPLETELY, BUT DILATATION WAS STARTED AT THE AREA JUST BEFORE REACHING THE LESION. THE PRESSURE DECREASED BEFORE REACHING THE NOMINAL PRESSURE, AND IT WAS THEN CONFIRMED THAT THE BALLOON RUPTURED. THE DEVICE WAS THEN REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383034 ↗
• MalfunctionNov 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT CIRCUMFLEX ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES AFTER 5 SECONDS, THE BALLOON RUPTURED DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098956 ↗
• MalfunctionNov 15, 2018Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT RESISTANCE WAS FELT AND THE SHAFT GOT SEVERELY KINKED AND HAD BEEN SEPARATED WHEN TRYING TO ADVANCED. THE PHYSICIAN USED ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER AND THE SAME ISSUES WERE ENCOUNTERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO ADVERSE EVENTS REPORTED AND THE PATIENT WAS ALRIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075419 ↗
• MalfunctionNov 15, 2018Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT RESISTANCE WAS FELT AND THE SHAFT GOT SEVERELY KINKED AND HAD BEEN SEPARATED WHEN TRYING TO ADVANCED. THE PHYSICIAN USED ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER AND THE SAME ISSUES WERE ENCOUNTERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO ADVERSE EVENTS REPORTED AND THE PATIENT WAS ALRIGHT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8075418 ↗
• MalfunctionNov 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED TO TREAT CHRONIC TOTAL OCCLUSION TARGET LESION. HOWEVER, DURING PROCEDURE THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038343 ↗
• MalfunctionOct 18, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND DIFFICULTY REMOVAL WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER DILATATION USING A 1.2MM X 12MM THREADER CATHETER, THE PHYSICIAN NOTICED THAT THE DEVICE WAS HARD TO REMOVE FROM THE BODY AND IT BROKE IN A HALF. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980966 ↗