PowerCross AB18W040040090Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684046272), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2018Deflation Problem; Deflation Problem
THE PHYSICIAN WAS ATTEMPTING TO USE A POWERCROSS BALLOON TO TREAT AN ARTERIOVENOUS FISTULA(AVF). THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. NO EMBOLIC PROTECTION WAS USED. THE BALLOON WAS INFLATED USING A AC3200 INFLATION DEVICE WITH 50/50 CONTRAST SALINE SOLUTION. THE DEVICE WAS REPORTED TO HAVE BEEN INFLATED TO A NORMAL ATM PRESSURE WITH NO ISSUES. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO DEFLATE THE DEVICE AND USED A NEEDLE TO PUNCTURE THE BALLOON THROUGH THE SKIN. THE BALLOON WAS THEN REMOVED. THERE WAS NO DAMAGE OR KINKING NOTED TO THE DEVICE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7435614 ↗
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 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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