2cm Peripheral Cutting Balloon® M001PCB8020900Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729813804), received between Oct 11, 2017 and Jul 31, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 29, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE GOT STUCK. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE GOT STUCK AFTER BALLOONING AND WAS SNARED TO REMOVE FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639805 ↗
• MalfunctionMar 27, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED AND WAS PUNCTURED TO REMOVE THE DEVICE. THE TARGET LESION WAS LOCATED IN THE FEMORAL AND POPLITEAL VEINS. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE DEFLATED AND HAD TO BE PUNCTURED TO REMOVE THE DEVICE FROM THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620076 ↗
• InjuryJul 11, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED AND TRAUMA OF PULLING OUT THE BALLOON CAUSED BLEEDING. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING A BILIARY STRICTURE PROTOCOL PROCEDURE, THE BALLOON WAS INFLATED FOR TREATMENT AND FOLLOWING THE COMPLETION OF TREATMENT, SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON TO NO AVAIL. FLUOROSCOPY WAS USED TO CONFIRM WHETHER THE BALLOON WAS STILL INFLATED, WHICH WAS INDEED THE CASE. AS A LAST RESORT EFFORT, THE PROVIDER FORCEFULLY PULLED BOTH THE SHEATH AND INFLATED BALLOON OUT OF THE PATIENT PROMPTLY PLACING A NEW BILIARY DRAINAGE CATHETER. THE TRAUMA OF PULLING OUT THE STILL FULLY INFLATED BALLOON CAUSED BLEEDING FROM THE ENTRY SITE THAT SUSTAINED BOTH IN THE PROCEDURE ROOM AND IN THE RECOVERY AREA FOR UP TO 4 HOURS. THE PROCEDURE WAS COMPLETED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED; THE PATIENT FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14976736 ↗
• InjuryOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED AND WAS REMOVED THROUGH A SNARE. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS AND A VERY MILD, INTIMAL FIBROSIS CALCIFIED FISTULA. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING WITHDRAWAL, RESISTANCE WAS FELT. WHEN THE DEVICE REACHED THE END OF THE SHEATH, IT WAS NOTED THAT THE BALLOON WAS DETACHED FROM THE CATHETER. THE CATHETER CAME OUT THROUGH THE SHEATH OVER THE WIRE AND WAS REMOVED ALTOGETHER LEAVING THE BALLOON WITHIN THE FISTULA. THE PHYSICIAN WAS ABLE TO ACCESS A NEW LOCATION SITE AND REMOVED THE BALLOON THROUGH SNARING. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT WAS WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569573 ↗
• MalfunctionDec 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. TWO 8.00MMX2.0CMX90CM PERIPHERAL CUTTING BALLOONS WERE SELECTED FOR USE ON THE DIALYSIS GRAFT. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 3 ATMOSPHERES. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS INSERTED INTO THE PATIENT. HOWEVER, THE SECOND BALLOON ALSO RUPTURED AND THE BLADES DID NOT COLLAPSE FULLY AND BECAME STUCK JUST OUTSIDE THE SHEATH WHEN ATTEMPTING TO REMOVE. A SNARE WAS USED TO GRAB THE STUCK BALLOON AND AID IN REMOVAL. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS PROLONGED DUE TO THIS EVENT. NO COMPLICATIONS WERE REPORTED AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10969459 ↗
• InjuryDec 8, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND WAS DIFFICULT TO REMOVE. TWO 8.00MMX2.0CMX90CM PERIPHERAL CUTTING BALLOONS WERE SELECTED FOR USE ON THE DIALYSIS GRAFT. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 3 ATMOSPHERES. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS INSERTED INTO THE PATIENT. HOWEVER, THE SECOND BALLOON ALSO RUPTURED AND THE BLADES DID NOT COLLAPSE FULLY AND BECAME STUCK JUST OUTSIDE THE SHEATH WHEN ATTEMPTING TO REMOVE. A SNARE WAS USED TO GRAB THE STUCK BALLOON AND AID IN REMOVAL. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS PROLONGED DUE TO THIS EVENT. NO COMPLICATIONS WERE REPORTED AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10969454 ↗
• MalfunctionJun 11, 2020Material Twisted/Bent; Material Twisted/Bent

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05JUNE2020. IT WAS REPORTED THAT A BENT BLADE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS CENTRAL VENOUS STENOSIS RIGHT BRACHIOCEPHALIC VEIN. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE IN A DIALYSIS ACCESS ANGIOPLASTY. DURING WITHDRAWAL, A BENT BLADE WAS NOTED. HOWEVER, IT WAS FURTHER REPORTED THAT THE DAMAGE OCCURRED AFTER IT WAS REMOVED FROM THE PATIENT VIA THE SHEATH. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A LIFTED 10MM BLADE AND PAD LIFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146025 ↗
• MalfunctionNov 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE LIFT OCCURRED. THE TARGET LESION AREA WAS LOCATED IN THE FISTULA. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE IT WAS NOTED THAT THE BLADE LIFTED AFTER IT WAS PULLED OUT FROM THE PATIENT'S FISTULA. THE DEVICE WAS COMPLETELY PULLED OUT USING A NON-BSC SHEATH. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292602 ↗
• MalfunctionJun 17, 2019Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT BALLOON BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE INNOMINATE VEIN. A 3 018/180 PLATINUM PLUS GUIDEWIRE AN A 2CM PERIPHERAL CUTTING BALLOON (PCB) WERE USED IN A PROCEDURE. WHEN THE PHYSICIAN PULLED THE PBC OUT OF THE SHEATH, THE TIP OF THE SHEATH BECAME DAMAGED AND THE BALLOON WAS STUCK. THE PHYSICIAN PULLED EVERYTHING OUT AND MANAGED TO KEEP THE WIRE ACCESS, BUT THE PHYSICIAN HAD TO CUT THE WIRE BECAUSE IT BECAME STUCK WITH THE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703910 ↗
• MalfunctionFeb 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLADE WAS PARTIALLY DETACHED FROM THE BALLOON. THE TARGET LESION WAS LOCATED IN FISTULA. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING WITHDRAWAL, ONE OF THE METAL BLADES CAME NEARLY OFF AND ABOUT HALF OF IT WAS SEPARATED; THE PROXIMAL HALF BROKE FREE AND WAS DANGLING ON THE BALLOON ITSELF AT ABOUT 90 DEGREES. THE DEVICE WAS THEN REMOVED THROUGH THE SHEATH FROM THE PATIENT'S BODY; BLADES REMAINED ON THE BALLOON AFTER REMOVAL. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. NO COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325700 ↗
• MalfunctionSep 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BLADE DETACHMENT OCCURRED. A 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN THE PHYSICIAN TOOK THE BALLOON OUT THROUGH THE PORT OF THE SHEATH, ONE OF THE BLADES PARTIALLY CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED AND LOOKED FINE AFTER POST ANGIOPLASTY. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENTS' STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877860 ↗
• MalfunctionSep 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BLADE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN 8.00MM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT WHEN THE PHYSICIAN TOOK THE BALLOON OUT THROUGH THE PORT OF THE SHEATH, ONE OF THE BLADES PARTIALLY CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS POST-PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877853 ↗
• MalfunctionAug 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BROKE APART AND WAS SNARED. A 8.00MM/90CM 2CM PERIPHERAL CUTTING BALLOON WAS USED DURING A VENOGRAM PROCEDURE. DURING PROCEDURE, THE BALLOON WAS INFLATED, AND THEN AS IT WAS DEFLATED, THE PHYSICIAN TRIED TO EXCHANGE IT OVER THE WIRE. IT WAS THEN NOTED THAT THE WHOLE BALLOON BROKE APART FROM THE CATHETER. THE BALLOON WAS THEN SNARED OUT AND A BIGGER SHEATH WAS USED TO RETRIEVE THE BROKEN DEVICE. ALL PARTS OF THE BALLOON WAS RETRIEVED AND NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING AN EXTRA LARGE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793881 ↗
• MalfunctionOct 11, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. A 8.00MM/2.0CM/90CM 2CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE INSIDE THE PATIENT. THE BALLOON WAS THEN RETRACTED OUTSIDE THE PATIENTS BODY AND ATTEMPTED TO INFLATE ON THE TABLE. DESPITE HAVING A 10ATM RATED BURST, 30ATM WAS USED TO GET THE FLUID INTO THE BALLOON. ONCE THE BALLOON FINALLY GOT FLUID INTO IT, IT WAS NOTED THAT THE FLUID WOULD NOT ASPIRATE OUT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6941961 ↗