Mach1Recalls & reported problems across all models
Boston Scientific Corporation · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls
- 0
We found 28 models of Mach1 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jul 5, 2018 and Dec 16, 2025 — classified as 1 death, 9 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Break” (20 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
Reports received per month, all models
Most reported Mach1 problems
Device problems
- Break20
- Detachment of Device or Device Component11
- Adverse Event Without Identified Device or Use Problem9
- Material Integrity Problem5
- Entrapment of Device4
- Fracture4
- Physical Resistance/Sticking4
- Unsealed Device Packaging4
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient9
- Vascular Dissection4
- No Patient Involvement3
- No Known Impact Or Consequence To Patient2
- Bradycardia1
- Burning Sensation1
- Cardiac Arrest1
Mach1 models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Mach1™ H749343565740CATHETER, PERCUTANEOUS8 reports
- Mach1™ H74934356220CATHETER, PERCUTANEOUS4 reports
- Mach1™ H749343566860CATHETER, PERCUTANEOUS4 reports
- Mach1™ H74934356720CATHETER, PERCUTANEOUS4 reports
- Mach1™ M001196480CATHETER, PERCUTANEOUS4 reports
- Mach1™ H749343566620CATHETER, PERCUTANEOUS2 reports
- Mach1™ M001196450CATHETER, PERCUTANEOUS2 reports
- Mach1™ M001196660CATHETER, PERCUTANEOUS2 reports
- Mach1™ M001197260CATHETER, PERCUTANEOUS2 reports
- Mach1™ M001198380CATHETER, PERCUTANEOUS2 reports
- Mach1™ H74934356103A0CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343565790CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934356520CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934356190CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934356260CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343562940CATHETER, PERCUTANEOUS1 death1 report
- Mach1™ H749343562970CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343566480CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343566640CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934356680CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934357010CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343575730CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343576920CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934357770CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343582790CATHETER, PERCUTANEOUS1 report
- Mach1™ H74934358480CATHETER, PERCUTANEOUS1 report
- Mach1™ H749343586860CATHETER, PERCUTANEOUS1 report
- Mach1™ M001198660CATHETER, PERCUTANEOUS1 report
Recent Mach1 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Break; Fluid/Blood Leak; Difficult to Remove; Material Perforation; Break; Fluid/Blood Leak; Difficult to Remove; Material Perforation
IT WAS REPORTED THAT THE SHAFT HOLE, BREAK AND BLOOD LEAKAGE OCCURRED. A 6F MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING ADVANCEMENT OF THE WIRE, A SMALL HOLE WAS NOTED AT THE FLUSH END OF THE CATHETER. THE WIRE WAS INADVERTENTLY PASSING THROUGH THIS HOLE, RESULTING IN BLOOD LEAKAGE. REMOVAL REQUIRED TWISTING, AND THE CATHETER END SUBSEQUENTLY SNAPPED. THERE NO PATIENT COMPLICATION REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS LESION. A HOLE WAS IDENTIFIED IN THE DISTAL PORTION OF THE CATHETER, OUTSIDE THE BODY, WHERE IT CONNECTS TO THE PRESSURE LINE. DIFFICULTY WAS ENCOUNTERED DURING DEVICE REMOVAL, AND THE DISTAL END OF THE CATHETER WAS CUT WITH SCISSORS TO ALLOW THE WIRE RETRIEVED FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE, AND THE PATIENT WAS WELL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23819316 ↗MalfunctionDec 8, 2025Nonstandard Device; Nonstandard Device
REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 17NOV2025. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. A 6F MACH 1 WAS SELECTED FOR USE. DURING INSPECTION OF THE PULLED-OUT ITEMS, IT WAS NOTED THAT THE UNIT WAS MARKED AS DEFECTIVE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743402 ↗MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 7F MACH 1 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22379443 ↗MalfunctionMay 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDE CATHETER BROKE. A MACH 1 GUIDE CATHETER WAS SELECTED AS PART OF TREATMENT OF THE TARGET LESION. AFTER THE GUIDE CATHETER WAS ADVANCED, IT WAS NOTICED THAT THE DISTAL END HAD COME OFF. THE DISCONNECTED PART OF THE CATHETER WAS STILL ON THE GUIDEWIRE AND WAS ABLE TO BE REMOVED WITH THE GUIDEWIRE. THE DEVICE WAS REMOVED FULLY BY PULLING IT NORMALLY OUT. ANOTHER OF THE SAME DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND PATIENT CONDITION IS NORMAL POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114797 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THAT CATHETER DETACHMENT OCCURRED. A MACH1 6F WAS SELECTED FOR USE. HOWEVER, AS THE PHYSICIAN INTRODUCED THE CATHETER, IT DETACHED. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS GOOD POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697833 ↗MalfunctionMar 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CATHETER FRACTURE OCCURRED. THE MACH 1 VL3.5 GUIDE CATHETER WAS SELECTED FOR USE. WHEN THE DEVICE WAS INTRODUCED, IT DETACHED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677417 ↗MalfunctionFeb 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRODUCT HAS A TEAR. A 6F MACH 1 CLS3.5 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PRODUCT HAS A TEAR. NO COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305836 ↗MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A MACH1 GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDE CATHETER WAS BROKEN. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21213954 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 85% STENOSED, 4.0-4.5MMX53MM, ECCENTRIC, DE NOVO TARGET LESION WITH A BEND OF >45 AND <90 DEGREES WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MIDDLE RIGHT CORONARY ARTERY (RCA). AN OPTICROSS IMAGING CATHETER WAS USED TO STUDY THE MORPHOLOGY OF THE LESION. AFTER A MACH1 JR 4 6F GUIDE-CATHETER WAS ENGAGED COAXIALLY AND A SAMURAI GUIDEWIRE CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 3.50MM X 15MM EMERGE BALLOON CATHETER. WITH THE HELP OF 6F GUIDEZILLA LONG CATHETER-GUIDE EXTENSION, A 4.0MM X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. A 4.0MM X 12MM NC EMERGE BALLOON CATHETER WAS THEN USED FOR POST DILATION. USING THE SAME OPTICROSS DEVICE, THE PHYSICIAN NOTED THAT A TYPE E DISSECTION HAD OCCURRED FROM THE PROXIMAL TO THE OSTIAL PART OF THE RCA. THE DISSECTION WAS CONSIDERED TO HAVE BEEN CAUSED BY THE GUIDEZILLA AND MACH1 CATHETERS. WHEN THEY WERE USED RESISTANCE WAS FELT, AND THE DEVICES WERE ENGAGED DEEPLY INTO THE RCA CAUSING THE DISSECTION. THE
Patient problems: Vascular Dissection
MAUDE report 20021026 ↗MalfunctionJun 26, 2024Break; Break
IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING A CORONARY CANNULATION PROCEDURE, A 6F MACH 1 GUIDE CATHETER BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19620051 ↗MalfunctionJun 12, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP BREAK OCCURRED. THE PATIENT UNDERWENT AN ARTERIOVENOUS FISTULA THROMBECTOMY. A TWO 90CM MACH 1 CATHER-GUIDE WERE SELECTED FOR USE. DURING THE PREPARATION, AFTER OPENING THE PRODUCT, IT WAS NOTED THAT THE TIP PART OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19524903 ↗MalfunctionJun 12, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP BREAK OCCURRED. THE PATIENT UNDERWENT AN ARTERIOVENOUS FISTULA THROMBECTOMY. A TWO 90CM MACH 1 CATHER-GUIDE WERE SELECTED FOR USE. DURING THE PREPARATION, AFTER OPENING THE PRODUCT, IT WAS NOTED THAT THE TIP PART OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19524897 ↗MalfunctionJun 10, 2024Break; Positioning Problem; Break; Positioning Problem
IT WAS REPORTED THAT THE DEVICE GOT SEPARATED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, A RESISTANCE WAS FELT, AND THE CATHETER COULD NOT BE ADVANCED TO THE DESIRED POSITION. EVENTUALLY THE CATHETER GOT SEPARATED IN THE OSTIUM OF DISTAL RCA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498191 ↗MalfunctionJun 10, 2024Break; Positioning Problem; Break; Positioning Problem
IT WAS REPORTED THAT THE DEVICE GOT SEPARATED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 6F MACH 1 CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, A RESISTANCE WAS FELT, AND THE CATHETER COULD NOT BE ADVANCED TO THE DESIRED POSITION. EVENTUALLY THE CATHETER GOT SEPARATED IN THE OSTIUM OF DISTAL RCA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498189 ↗InjuryFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. AN 8F MACH 1 GUIDE CATHETER WAS SELECTED FOR USE. AFTER THE PROCEDURE WAS COMPLETED, A SMALL RING-SHAPED OBJECT WAS OBSERVED FLOATING IN THE LEFT VENTRICLE. THE PHYSICIAN THOUGHT THAT THE TIP OF THE GUIDE CATHETER HAD FALLEN OFF. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18754497 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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