Chocolate® CB1413535120OTWRecalls & reported problems
Medtronic, Inc. · PTA CB1413535120 CHOCOLATE 014 V04 · Class 2
All models of Chocolate (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000430436), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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
Device problems
- Device Damaged by Another Device1
- Difficult to Remove1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2023Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device
A PHYSICIAN WAS USING A CHOCOLATE PTA BALLOON FOR THE TREATMENT OF A 150MM-200MM PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION IN THE S UPERFICIAL FEMORAL (SFA) AND ARTERY POPLITEAL ARTERY (POP). THE ARTERY DIAMETER WAS 6MM WITH NO TORTUOSITY AND MILD CALCIFICATION. A 6FR NON-MEDTRONIC SHEATH AND A 0.018 GUIDEWIRE WERE USED. 50.50 CONTRAST HEP SALINE INFLATION FLUID WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE PATIENT HAD IN DWELLING SFA/POP NON-MEDTRONIC STENTS, IN THE SFA AND POP. DUE TO PATIENT NONCOMPLIANCE THE STENTS WERE CLOTTED OFF AND A BOSTON SCI ANGIO JET WAS CHOSEN IN CONJUNCTION WITH TPA TO REMOVE CLOT BURDEN FROM THE STENTS. INITIAL PASS OF THE ANGIO JET WERE FINE, AND ANGIOGRAM SHOWED RESIDUAL OBSTRUCTION, SO THE DEVICE WAS USED AGAIN WITH TPA AND I NOTICED THE ANGIO JET JUMP AT THE JUNCTION OF THE TWO STENTS, BUT IT WAS ADVANCED AND THE PROCEDURE WAS CONTINUED. AFTER THE DEVICE WAS REMOVED A NON-MEDTRONIC WIRE 0.018 WAS THEN PLACED IN THE POSTERIOR TIBIAL PAST THE ANKLE JOINT AND THE 3.5/120 CHOCOLATE BALLOON WAS THEN ADVANCED, AND A SUCCESSFUL PTA WAS COMPLETED. THE CHOCOLATE BALLOON WAS THEN REMOVED AND THEN A 5.0/20
Patient problems: Insufficient Information
MAUDE report 16656391 ↗
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 16, 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