Pacific™ Plus PCP060300150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477072029), received between Nov 20, 2025 and Jan 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A POST-DILATION BALLOON PROCEDURE, WHICH WAS THE FINAL STEP OF TREATMENT FOR PLAQUE IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (PERIPHERAL ARTERY DISEASE), A BALLOON TWIST/DOG-BONE TWIST WAS VISIBLE WITHIN THE BALLOON IN THE VESSEL USING A PACIFIC PLUS US CATHETER. THE ARTERY DIAMETER WAS 6 MILLIMETERS AND THE DEGREE OF TORTUOSITY WAS MINIMAL. EMBOLIC PROTECTION WAS USED WITH A SPIDERFX DEVICE. THE BALLOON WAS INFLATED WITH A 50/50 CONTRAST SOLUTION USING AN INFLATION DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108659 ↗
• MalfunctionNov 20, 2025Deflation Problem; Difficult to Insert; Deflation Problem; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING THE CATHETER AND THE PACIFIC PLUS WAS SLOW TO DEFLATE. THE SHEATH USED WAS A 6FR NON MEDTRONIC DEVICE, AND THE VESSEL WAS PRE-DILATED WITH A MEDTRONIC PACIFIC PLUS DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. THE BALLOON WAS INFLATED USING A INFLATIONS DEVICE AND NO ISSUES WERE NOTED DURING INFLATION. CONTRAST/SALINE INFLATION FLUID WAS USED (% UNKNOWN). THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL NORMALLY, THE ISSUE WAS THE BALLOON WAS NOT ABLE TO BE RE-INSERTED FOR A 2ND TIME. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606383 ↗