PACIFIC XTREME PCU060150130 (UDI 08033477075839)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08033477075839), received between May 26, 2020 and Nov 7, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K103464); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FRENCH 45CM NON-MEDTRONIC SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT'S PROXIMAL RIGHT POPLITEAL ARTERY. SEVERE VESSEL CALCIFICATION IS REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 SALINE CONTRAST MIX FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT.  A BALLOON BURST IS REPORTED AY 8ATM ON FIRST INFLATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. A SECOND PACIFIC XTREME PTA BALLOON WAS OPENED AND PREPPED WITHOUT ISSUE. THE SECOND PACIFIC XTREME BALLOON BURST AT 8ATM ON FIRST INFLATION. NO BALLOON FRAGMENTATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO VESSEL DAMAGE. AN ADDITIONAL BALLOON OF THE IDENTICAL SIZE WAS TAKEN FROM THE CUSTOMERS CONSIGNMENT TO COMPLETE THE ANGIOPLASTY. NO PATIENT INJURY RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758111 ↗
• MalfunctionMar 19, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA DURING PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED WITH BALLOON TWIST NOTED AT 6ATM. A REWRAP ISSUE WAS NOTED. A SECOND PACIFIC XTREME WAS ATTEMPTING AND SAME ISSUE OCCURRED. A TWIST WAS NOTED DURING BALLOON INFLATION AT 6ATM. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527780 ↗
• MalfunctionMar 19, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A PACIFIC XTREME PTA DURING PROCEDURE TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON INFLATION DIFFICULTIES OCCURRED WITH BALLOON TWIST NOTED AT 6ATM. A REWRAP ISSUE WAS NOTED. A SECOND PACIFIC XTREME WAS ATTEMPTING AND SAME ISSUE OCCURRED. A TWIST WAS NOTED DURING BALLOON INFLATION AT 6ATM. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527724 ↗
• MalfunctionOct 20, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A PIN HOLE BURST ON THE BALLOON IS REPORTED AT INFLATION PRESSURE OF 12ATM. THE BALLOON WAS REMOVED, AND NO OTHER TREATMENT WAS PERFORMED AS IT WAS THE END OF THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10703741 ↗
• MalfunctionMay 26, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON TO POST-DILATE A NON-MEDTRONIC STENT DURING TREATMENT OF A 300MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS PASSED THROUGH THE DEPLOYED STENT WITHOUT ENCOUNTERING RESISTANCE POST ATHERECTOMY. IT IS REPORTED THAT DURING ATTEMPTED INFLATION, DOG-BONING WAS OBSERVED AT AN INFLATION PRESSURE OF 3ATM. THE DEVICE WAS REPLACED WITH ANOTHER PACIFIC XTREME DEVICE, BUT THE SAME ISSUE WAS EXPERIENCED AT AN INFLATION PRESSURE OF 6ATM. THERE WAS NO TWIST OR KINK NOTED ON THE BALLOONS WHEN REMOVED FROM THE PATIENT. BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE OCCURRED. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. A NON-MEDTRONIC STENT WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086274 ↗
• MalfunctionMay 26, 2020Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN INTENDED TO USE A PACIFIC XTREME PTA BALLOON TO POST-DILATE A NON-MEDTRONIC STENT DURING TREATMENT OF A 300MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6MM. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS PASSED THROUGH THE DEPLOYED STENT WITHOUT ENCOUNTERING RESISTANCE POST ATHERECTOMY. IT IS REPORTED THAT DURING ATTEMPTED INFLATION, DOG-BONING WAS OBSERVED AT AN INFLATION PRESSURE OF 3ATM. THE DEVICE WAS REPLACED WITH ANOTHER PACIFIC XTREME DEVICE, BUT THE SAME ISSUE WAS EXPERIENCED AT AN INFLATION PRESSURE OF 6ATM. THERE WAS NO TWIST OR KINK NOTED ON THE BALLOONS WHEN REMOVED FROM THE PATIENT. BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT. NO VESSEL DAMAGE OCCURRED. A NON-MEDTRONIC BALLOON WAS USED TO COMPLETE THE PROCEDURE. A NON-MEDTRONIC STENT WAS PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103464. One submission often covers many models, so check the product and lot details in each record.

• Z-3055-2020 · Aug 26, 2020 · Terminated
  Pacific Xtreme (PTCA Balloon Dilation Catheter)