EverCross™ AB35W07040135 (UDI 00821684061848)Recalls & reported problems
Ev3, Inc · PTA AB35W07040135 EVERCROSS 035 V05 · 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 00821684061848), received between May 28, 2019 and May 28, 2019 — 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 (K103322); 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
- 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.
MalfunctionMay 28, 2019Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED AN EVERCROSS 035 WITH A NON-MEDTRONIC 6FR (TERUMO) SHEATH AND (DESTINATION) .035 WIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID LEFT COMMON ILIAC ARTERY. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC (BOSTON SCIENTIFIC ENCORE 26) INFLATION DEVICE WAS USED WITH CONTRAST AND SALINE FOR INFLATION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, AND NO EXCESSIVE FORCE USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED A BALLOON BURST OCCURRED AT 10ATM ON SECOND INFLATION. ALL BALLOON FRAGMENTS WERE RETRIEVED. NO ADDITIONAL INFLATIONS WERE REQUIRED AFTER RUPTURE. PROCEDURE COMPLETED AT THIS POINT. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8645219 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103322. One submission often covers many models, so check the product and lot details in each record.
- Z-1489-2014 · Apr 9, 2014 · Terminatedev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W
Other Catheter, angioplasty, peripheral, transluminal devices
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- 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 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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