2cm Peripheral Cutting Balloon® M001PCB80201350Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729813781), received between May 22, 2020 and Jan 6, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 18, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BLADE DETACHED AND REQUIRED ADDITIONAL INTERVENTION. THE TARGET LESION AREA WAS LOCATED IN THE LEFT PULMONARY ARTERY. A 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CUTTING BALLOON WAS BEING REMOVED AND RESISTANCE WAS NOTED. HOWEVER, IT WAS NOTED THAT ONLY 3 BLADES WERE SEEN ON THE BALLOON. THE SHEATH WAS EXCHANGED AND THE BLADE WAS NOT SEEN. SUBSEQUENTLY, THE PHYSICIAN CONFIRMED THAT THERE WAS A BLADE MISSING BY OPENING ANOTHER PERIPHERAL CUTTTING BALLOON FOR COMPARISON. THE DETACHED BLADE WAS LOCATED IN THE LUNG BY FLUOROSCOPY. SNARE WAS PERFORMED TO RETRIEVED THE BLADE AND WAS SUCCESSFUL. THE PATIENT IS STABLE. NO COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT PULMONARY STENOSIS IN THE PULMONARY VALVES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860900 ↗
• MalfunctionOct 19, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON WOULD NOT DEFLATE. AN 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE AFTER 12 MULTIPLE INFLATIONS. SUBSEQUENTLY, THE BALLOON WAS REMOVED AS A SYSTEM WHILE INFLATED USING 12F SHEATH TO ASSIST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10697268 ↗
• InjuryJul 30, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND DAMAGED THE FISTULA. THE TARGET LESION WAS LOCATED IN THE FISTULA IN THE ARM. AN 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING REMOVAL, THE BALLOON FAILED TO DEFLATE. THERE WERE MULTIPLE FAILED ATTEMPTS TO DEFLATE THE BALLOON BY PULLING NEGATIVE PRESSURE. THE BALLOON APPEARED TO HAVE BEEN DEFLATED WHEN REACHED THE TIP OF THE SHEATH FOR REMOVAL, HOWEVER IT WAS NOT DEFLATED. THE BALLOON AND SHEATH WERE REMOVED AS A SYSTEM WHICH RESULTED IN DAMAGE OF THE FISTULA AND THE SKIN AT THE INSERTION POINT. THE FISTULA WAS THEN CLOSED TO THE SKIN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10344994 ↗
• InjuryMay 22, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AND ADDITIONAL INTERVENTION WAS REQUIRED. THE TARGET LESION WAS LOCATED IN THE LEFT PULMONARY ARTERY. A 8.00MM/2.0CM/135CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, AFTER POSITIONING AND INFLATION, THE BALLOON WOULD NOT DEFLATE DESPITE THE PRESSURE WAS PULLED TO NEGATIVE PRESSURE OF 60CC. CONSEQUENTLY, THE HUB WAS CUT OFF OF BALLOON CATHETER AND PHYSICIAN WENT OVER WITH A 12F SHEATH PLACED AGAINST THE PROXIMAL END OF BALLOON. FINALLY, THE BALLOON WAS ABLE TO BE PULLED WHILE INFLATED INTO THE SHEATH AND ALL SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10082801 ↗