Pacific™ Plus PCP020040150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477071596), received between May 20, 2024 and Mar 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Leak/Splash

  A PHYSICIAN ATTEMPTED TO USE A (B (4) PACIFIC PLUS PTA BALLOON TO TREAT A CALCIFIED LESION IN A PATIENT. THE BALLOON WAS SUCCESSFULLY PREPPED, INSERTED, INFLATED, DEFLATED, AND REMOVED ONCE WITH NO ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO FLUSH TO PREPARE FOR A SECOND INSERTION <(>&<)> USE, THE SALINE SOLUTION WAS INJECTED INTO THE APPROPRIATE PORT TO FLUSH THE CATHETER LUMEN, THE SOLUTION CAME OUT THE BALLOON PORT INSTEAD. THE BALLOON WAS NOT USED AFTER THIS DISCOVERY. IT WAS NOTED THAT THE VESSEL WAS HEAVILY CALCIFIED, AND THAT THERE WERE OTHER UNKNOWN DEVICES USED THROUGHOUT THE PROCEDURE (SUCH AS WIRES/CATHETERS) THAT HAD BECOME KINKED WITH NORMAL USE, BUT IT WAS UNCLEAR IF THAT WAS THE CAUSE OF THE ISSUE OR IF THERE WAS A DEFECT IN THE BALLOON. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495722 ↗
• MalfunctionMay 20, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A PACIFIC PLUS PTA BALLOON WITH A 6X45 NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A .018 NON-MEDTRONIC (ABBOTT COMMAND) GUIDEWIRE DURING TREATMENT OF AN 80MM CALCIFIED LESION IN THE PATIENT¿S LEFT DISTAL ANTERIOR TIBIAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 2.5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. A NON-MEDTRONIC (BOSTON SCIENTIFIC ENCORE) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. INFLATION DIFFICULTIES WERE REPORTED. THE BALLOON WOULDN¿T MAINTAIN PRESSURE. NO LEAKS WERE NOTED ON THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349938 ↗