Chocolate® PTA Balloon Catheter CB1812060080OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1812060080 CHOCOLATE 018 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00763000115265), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
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.
MalfunctionOct 21, 2021Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE CHOCOLATE PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND "0.018" 300CM GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 80MM RESPECTIVELY. A 50/50 CONTRAST AND SALINE WERE USED FOR INFLATION FLUID. 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 DURING INITIAL BALLOON INFLATION, A BURST/RUPTURE/LEAK OCCURRED WHEN BALLOON WAS BROUGHT UP TO 2-4ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE CHOCOLATE BALLOON WAS USED PER MEDTRONIC IFU, THE INFLATION WAS BEING BROUGHT TO HALF THE NOMINAL ATMS OVER THE FIRST 30 SEC WHEN BLOOD WAS NOTED IN THE INFLATION SYRINGE. THE BALLOON WAS THEN REMOVED AND A NEW CHOCOLATE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12670553 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page