PowerCross AB18W030120150Recalls & reported problems
Covidien LP · .018 · Class 2
All models of PowerCross (12)
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 00821684046654), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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. 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 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.
MalfunctionAug 9, 2017Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED A POWERCROSS PTA BALLOON FOR THE TREATMENT OF A MODERATELY CALCIFIED, SLIGHTLY TORTUOUS LESION IN THE MID POPLITEAL ARTERY. LESION EXHIBITED 80% STENOSIS. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, BUT EXCESSIVE FORCE WAS NOT USED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST IS REPORTED AT A PRESSURE OF 13ATMS DURING INFLATION. ALL FRAGMENTS WERE RETRIEVED AND A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776192 ↗
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.
Other Catheter, angioplasty, peripheral, transluminal devices
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- 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.
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