Pacific™ Plus PCP030120150Recalls & reported problems
Medtronic, Inc. · CATH PCP030120150 PCP D3.00 L 120 UL 150 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477071701), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING A CO2 ANGIOGRAM OF THE RIGHT LEG, DIFFUSE DISEASE WAS OBSERVED THROUGHOUT THE ENTIRE RIGHT ANTERIOR TIBIAL ARTERY. THE LESION LENGTH WAS 250MM AND THE TARGET LESION WAS PLAQUE. LESION STENOSIS WAS 60-70%. THERE WAS MINIMAL TORTUOSITY AND CALCIFICATION. THE ARTERY WAS 3MM IN DIAMETER. A PACIFIC PLUS BALLOON WAS USED FOR A THREE-SEGMENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (DISTAL, MIDDLE, PROXIMAL). AFTER THE INITIAL PROCEDURE, A FOLLOW-UP CO2 ANGIOGRAM SHOWED MINIMALLY IMPROVED FLOW, PROMPTING A REPEAT OF THE ANGIOPLASTY. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO BACK OUT THE BALLOON OVER THE WIRE, AS IT KEPT GETTING CAUGHT. THE BALLOON WAS FULLY DEFLATED, THE BALLOON CATHETER WAS FLUSHED, AND THE WIRE WAS WET. THE WIRE WAS CHANGED BUT DESPITE USING A NEW WIRE, THE ISSUE PERSISTED. PTA WAS THEN DONE ON THE PROXIMAL SEGMENT OF THE RIGHT ANTERIOR TIBIAL ARTERY. WHEN THAT WAS DONE, AND THE BALLOON WAS FULLY DEFLATED, THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE BALLOON OVER THE WIRE AGAIN, AND EVEN WITH GREAT FORCE WAS UNABLE TO BACK THE BALLOON OUT. THE PHYSICIAN ULTIMATELY REMOVED BOTH THE WIRE AND THE BALLOON TOGETHER, RISKING L
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322240 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.