2cm Peripheral Cutting BalloonRecalls & reported problems across all models

We found 12 models of 2cm Peripheral Cutting Balloon by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2017 and Apr 16, 2026 — classified as 14 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 2cm Peripheral Cutting Balloon problems

2cm Peripheral Cutting Balloon models

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

• 2cm Peripheral Cutting Balloon® M001PCB8020900

  Catheter, percutaneous, cutting/scoring
  18 reports
• 2cm Peripheral Cutting Balloon® M001PCB50201350

  Catheter, percutaneous, cutting/scoring
  6 reports
• 2cm Peripheral Cutting Balloon® M001PCB60201350

  Catheter, percutaneous, cutting/scoring
  6 reports
• 2cm Peripheral Cutting Balloon® M001PCB6020900

  Catheter, percutaneous, cutting/scoring
  5 reports
• 2cm Peripheral Cutting Balloon® M001PCB7020900

  Catheter, percutaneous, cutting/scoring
  5 reports
• 2cm Peripheral Cutting Balloon® M001PCB80201350

  Catheter, percutaneous, cutting/scoring
  5 reports
• 2cm Peripheral Cutting Balloon® M001PCB6020500

  Catheter, percutaneous, cutting/scoring
  4 reports
• 2cm Peripheral Cutting Balloon® M001PCB8020500

  Catheter, percutaneous, cutting/scoring
  4 reports
• 2cm Peripheral Cutting Balloon® M001PCB5020500

  Catheter, percutaneous, cutting/scoring
  2 reports
• 2cm Peripheral Cutting Balloon® M001PCB5020900

  Catheter, percutaneous, cutting/scoring
  2 reports
• 2cm Peripheral Cutting Balloon® M001PCB70201350

  Catheter, percutaneous, cutting/scoring
  1 report
• 2cm Peripheral Cutting Balloon® M001PCB7020500

  Catheter, percutaneous, cutting/scoring
  1 report

Recent 2cm Peripheral Cutting Balloon adverse event reports

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

• MalfunctionApr 16, 2026Material Rupture

  IT WAS REPORTED A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 100% STENOSIS, WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY, INVOLVING IN-STENT RESTENOSIS WITHIN PREVIOUSLY PLACED STENTS IN THE P1 AND P2 SEGMENTS OF THE POPLITEAL ARTERY, WITH ADDITIONAL DISTAL DISEASE. THE AFFECTED SEGMENT WAS PRE-DILATED USING A 5.0 X 120 MM STERLING BALLOON INFLATED TO NOMINAL PRESSURE. IT WAS NOTED THAT THE STENT IN THE P2 SEGMENT WAS UNDERSIZED, RESULTING IN A FLOW-LIMITING NARROWING. A 5.0 MM X 20 MM X 135 CM OTW PERIPHERAL CUTTING BALLOON WAS ADVANCED OVER A V18 GUIDEWIRE TO TREAT THE LESION. DURING INFLATION AT 10 ATMOSPHERES FOR APPROXIMATELY 10 SECONDS WITHIN THE P2 SEGMENT, BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT COMPLICATION. A SECOND 6.0 MM X 20 MM OTW PERIPHERAL CUTTING BALLOON WAS SUBSEQUENTLY ADVANCED TO THE SAME SEGMENT AND INFLATED TO 10 ATMOSPHERES; BALLOON RUPTURE AGAIN OCCURRED DURING INFLATION. THE DEVICE WAS REMOVED WITHOUT RESISTANCE. FOLLOWING THESE EVENTS, A 5.0 X 40 MM X 135 CM CHARGER BALLOON WAS ADVANCED AND INFLATED TO 20 ATMOSPHERES. THEREAFTER, A 5.0 X 150 MM X 150 CM RANGER DEVICE WAS USED TO TREAT THE DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896890 ↗
• MalfunctionApr 16, 2026Material Rupture

  IT WAS REPORTED A BALLOON RUPTURE OCCURRED. THE TARGET LESION, EXHIBITING 100% STENOSIS, WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY, INVOLVING IN-STENT RESTENOSIS WITHIN PREVIOUSLY PLACED STENTS IN THE P1 AND P2 SEGMENTS OF THE POPLITEAL ARTERY, WITH ADDITIONAL DISTAL DISEASE. THE AFFECTED SEGMENT WAS PRE-DILATED USING A 5.0 X 120 MM STERLING BALLOON INFLATED TO NOMINAL PRESSURE. IT WAS NOTED THAT THE STENT IN THE P2 SEGMENT WAS UNDERSIZED, RESULTING IN A FLOW-LIMITING NARROWING. A 5.0 MM X 20 MM X 135 CM OTW PERIPHERAL CUTTING BALLOON WAS ADVANCED OVER A V18 GUIDEWIRE TO TREAT THE LESION. DURING INFLATION AT 10 ATMOSPHERES FOR APPROXIMATELY 10 SECONDS WITHIN THE P2 SEGMENT, BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED WITHOUT COMPLICATION. A SECOND 6.0 MM X 20 MM OTW PERIPHERAL CUTTING BALLOON WAS SUBSEQUENTLY ADVANCED TO THE SAME SEGMENT AND INFLATED TO 10 ATMOSPHERES; BALLOON RUPTURE AGAIN OCCURRED DURING INFLATION. THE DEVICE WAS REMOVED WITHOUT RESISTANCE. FOLLOWING THESE EVENTS, A 5.0 X 40 MM X 135 CM CHARGER BALLOON WAS ADVANCED AND INFLATED TO 20 ATMOSPHERES. THEREAFTER, A 5.0 X 150 MM X 150 CM RANGER DEVICE WAS USED TO TREAT THE DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896881 ↗
• MalfunctionApr 2, 2026Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE SHEATH AND DAMAGED THE SHEATH. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS GRAFT STENOSIS. AN 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS USED. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. PRIOR TO REMOVAL, THE BALLOON WAS FULLY DEFLATED, HOWEVER, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SHEATH AND SLICING IT OPEN. A SURGICAL CUTDOWN WAS DONE TO REMOVE THE DEVICE FROM THE PATIENT. ANOTHER 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES. PRIOR TO REMOVAL, THE BALLOON WAS FULLY DEFLATED, HOWEVER, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE SHEATH AND SLICING IT OPEN. THE BALLOON AND THE SHEATH WERE REMOVED SAFELY. A NEW SHEATH WAS INSERTED SO CLOSURE COULD BE SECURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767752 ↗
• InjuryJan 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON BROKE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN 8.00MM/2.0CM/135CM 2CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PART OF THE BALLOON WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE MILD TORTUOUS WAS LOCATED THE ARTERY. THE DEVICE WAS REMOVED USING SNARING AND THE PROCEDURE WAS COMPLETED USING DIFFERENT BALLON PLAIN OLD BALLOON ANGIOPLASTY (POBA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977286 ↗
• MalfunctionJul 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. AN 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS ADVANCE FOR DILATION. DURING THE PROCEDURE, THE CUTTING BALLOON WAS BURST AND WAS NOT INFLATED TO THE NOMINAL PRESSURE, LET ALONE THE RATED BURST PRESSURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681331 ↗
• InjuryJul 24, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED, REQUIRING THE USE OF A NEEDLE TO DEFLATE IT. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO LESS THAN 10 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT DEFLATE DURING THE ATTEMPT TO DEFLATE IT. MULTIPLE ATTEMPTS WERE MADE, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN HAD TO PLACE A SMALL NEEDLE THROUGH THE PATIENT'S SKIN TO PUNCTURE THE BALLOON IN THE PATIENT'S ARM. A FISTULA WAS BEING TREATED IN THE ARM AND THE VESSEL IS REALLY SUPERFICIAL SO PLACING A NEEDLE IS A VERY EASY PROCESS TO GET TO THE BALLOON. IT TOOK 5 MINUTES TO DEFLATE THE BALLOON. THE BALLOON WAS FULLY DEFLATED AND REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588608 ↗
• MalfunctionMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. A 5.00 MM/2.0 CM/135 CM PERIPHERAL CUTTING BALLOON CATHETER WAS PREPARED AND ADVANCED INTO THE PATIENT FOR ANGIOPLASTY. HOWEVER, UPON INFLATION, THE BALLOON DID NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND EXAMINED ON THE BACK TABLE, WHERE A HOLE WAS FOUND IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689999 ↗
• MalfunctionFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS FISTULA IN THE UPPER EXTREMITY. A 6.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON CATHETER WAS ADVANCED ACROSS THE NARROW ARTERIAL ANASTOMOSIS. DURING SEVERAL DILATION, THE BALLOON WOULD NOT INFLATE ABOVE 5 ATMOSPHERES AND WOULD NOT HOLD THAT PRESSURE. IT WAS DETERMINED THAT THE BALLOON MUST HAVE BURST. THE BALLOON WAS PULLED OUT OF THE SHEATH AND USED A PLAIN OLD BALLOON ANGIOPLASTY TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON BURST WAS CONFIRMED, AS THE CONTRAST WAS NOTED TO BE COMING OUT OF THE BALLOON. THE BALLOON WAS INFLATED TWICE UP TO 4 ATMOSPHERES WHEN IT RUPTURED. THE BLADES WERE UNABLE TO FOLD COMPLETELY DURING REMOVAL, CAUSING THE SHEATH TO BE SLICED ON THE WAY OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393828 ↗
• MalfunctionDec 1, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS ADVANCED OVER THE WIRE INTO THE FISTULA. DURING FIRST INFLATION, THE BALLOON DID NOT INFLATE AND POPPED FOR UNKNOWN REASON. THE DEVICE WAS REMOVED INTACT WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20815491 ↗
• InjuryOct 11, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BLADE DAMAGED THE SHEATH CAUSING SIGNIFICANT BLEEDING TO THE PATIENT. AN 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON CATHETER WAS SELECTED FOR FISTULA DECLOT PROCEDURE. DURING REMOVAL, THE BALLOON WAS FULLY DEFLATED AND WAS REMOVE THROUGH THE SHEATH, BUT DIFFICULTIES WERE ENCOUNTERED. THE BLADES DAMAGED THE SHEATH AS WELL AS THE ACCESS SITE, CAUSING SIGNIFICANT BLEEDING TO THE PATIENT. AFTER THE DEVICE WAS FULLY REMOVED FROM THE PATIENT, THERE WAS NO PHYSICAL DAMAGE FOUND TO THE BALLOON. THE PHYSICIAN TIED A PURSE STRING SUTURE TO CONTROL THE BLEEDING AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20429163 ↗
• MalfunctionJul 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INFLATION AT 6-8 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860126 ↗
• MalfunctionJun 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON PERFORATION OCCURRED. AN 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR TREATMENT AND IT APPEARED THAT THE WIRE HAD PUNCTURED THROUGH THE BALLOON, NOT EXITING THE DISTAL TIP AS IT SHOULD. NO FURTHER INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC REGARDING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481538 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE WAS NOTED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE, AND A HOLE WAS NOTED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673239 ↗
• MalfunctionJan 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BLADE DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS ARTERIOVENOUS FISTULA. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, A 7FR NON-BOSTON SCIENTIFIC SHEATH WAS PLACED IN THE VESSEL AND A 0.35 MUSTANG BALLOON CATHETER WAS USED FIRST. SUBSEQUENTLY, ANGIOGRAPHY SHOWS RESIDUAL STENOSIS, SO A CUTTING BALLOON WAS NEEDED. THE PCB DEVICE WAS OPENED AND LOADED ONTO A V-18 GUIDEWIRE ACROSS THE LESION AND THEN INFLATED TO NOMINAL PRESSURE. THE DEVICE WAS THEN REMOVED AND FOUND THE METAL CUTTERS WERE COMING OFF THE BALLOON. ALL THE METAL CUTTING PIECES OF THE BALLOON WERE ACCOUNTED FOR AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484123 ↗
• MalfunctionNov 29, 2023Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN 8.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE BALLOON WAS REMOVED AND UPON TRYING TO INFLATE, A LEAK AND A TINY HOLE WAS NOTED IN THE BALLOON. 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 18230711 ↗

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