PowerCross AB18W050200150Recalls & reported problems
Covidien LP · .018 · Class 2
Data updated Oct 13, 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 00821684046838), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K093286); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Difficult to Remove1
- Inflation Problem1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2017Inflation Problem; Difficult to Remove; Retraction Problem; Inflation Problem; Difficult to Remove; Retraction Problem
PHYSICIAN USED A POWERCROSS PTA BALLOON FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY WITHOUT THE USE OF EMBOLIC PROTECTION. THERE WAS NO DAMAGING TO PACKAGING AND DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED INFLATION DIFFICULTIES. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON FOLLOWING INFLATION, DIFFICULTY WAS ENCOUNTERED AS THE BALLOON WOULD NOT COME BACK THROUGH THE SHEATH. THE SHEATH, WIRE, AND BALLOON WERE REMOVED AS ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6628334 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K093286. One submission often covers many models, so check the product and lot details in each record.
- Z-0892-2017 · Nov 10, 2016 · Terminatedev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, po
- Z-1552-2016 · Mar 29, 2016 · Terminatedev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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