NanoCross™ AB14W025210150Recalls & reported problems
Ev3, Inc · PTA AB14W025210150 NANOCROSS 014 V03 · 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 00821684059463), received between Mar 21, 2017 and Mar 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 other recall cover devices cleared under the same FDA submission (K082854); 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.
MalfunctionMar 21, 2017Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING THE PROCEDURE, THE NANOCROSS 0.14 OTW PTA DILATATION CATHETER BALLOON BURST. IT WAS REPORTED THAT THERE WAS NO CALCIFICATION OR TORTUOSITY PRESENT IN THE VESSEL. IT WAS REPORTED THAT THE PHYSICIAN RETRIEVED THE DEVICE AND COMPLETED THE PROCEDURE USING ANOTHER DEVICE OF THE SAME MODEL. NO VESSEL DAMAGE WAS EXPERIENCED. THE PATIENT WAS DESCRIBED AS BEING IN A STABLE CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6420267 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082854. One submission often covers many models, so check the product and lot details in each record.
- Z-0789-2011 · Nov 12, 2010 · Terminatedev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14
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- 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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