Zenapro G35477Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002354774), received between Mar 28, 2016 and Mar 28, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2016Device Operates Differently Than Expected

  THE PATIENT HAD A FEW SMALL MIDLINE INCISION HERNIAS. ON (B)(6) 2016, DR. (B)(6) PLACED A C-HYB-10X15 AND A PERITONEAL DIALYSIS CATHETER. THE OPERATION WAS PERFORMED LAPAROSCOPICALLY. THE GRAFT WAS PLACED INTRAPERITONEALLY (UNDERLAY), IT WAS NOT CUT OR TRIMMED AND ABSORBA-TACKS WERE USED TO FIXATE THE GRAFT. THE GRAFT WAS PLACED WITH THE ACCORDING TO SIDEDNESS RECOMMENDATIONS. EXTENSIVE ADHESIONS WERE NOT NOTED DURING THIS OPERATION. THE FOLLOWING WEEK, THE PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM DUE TO CONCERN FOR A CLOSED LOOP BOWEL OBSTRUCTION. THE PATIENT HAD NOT HAD ANY PERITONEAL DIALYSIS TREATMENTS AT THIS POINT. UPON REOPERATION, A BOWEL OBSTRUCTION WAS NOT DISCOVERED, BUT THE PATIENT DID HAVE EXTENSIVE ADHESIONS TO THE MESH. THIS OPERATION WAS PERFORMED IN AN OPEN MANNER BY DR. (B)(6). THE ZENAPRO WAS REMOVED AND A PRIMARY CLOSURE OF THE MIDLINE WAS PERFORMED.

  Patient problems: Hernia

  MAUDE report 5529371 ↗