CODMAN® 831325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780521402), received between Sep 15, 2022 and Sep 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjurySep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED: "PATIENT WENT APNEIC AND DESATED. ¿PPV¿ STARTED AND THEN HEART RATE (HR) DROPPED BELOW 60 AND CHEST COMPRESSIONS STARTED. NEONATAL TEAM CALLED TO ROOM. AFTER VENTRICULOPERITONEAL (VP) SHUNT SURGERY PATIENT DEVELOPED PNEUMOPERITONEUM. THE PATIENT WAS TAKEN BACK TO OPERATING ROOM (OR) WHERE THE VP SHUNT WAS FOUND TO BE THROUGH ANTERIOR AND POSTERIOR WALL OF STOMACH AT LESSER CURVATURE, AND THROUGH TRANSVERSE COLONIC MESENTERY. THE SHUNT WAS REMOVED FROM THE STOMACH AND BOTH DEFECTS WERE OVER SEWN. THE PATIENT HAD RETURNED FROM THE OR APPROXIMATELY 30 MINUTES PRIOR TO EVENT. TRANSITIONED TO NC (NASAL CANNULA), THEN WENT APNEIC. CODMAN SPLIT SHEATH TROCAR WENT THROUGH ANTERIOR AND POSTERIOR WALLS OF THE STOMACH. THE CATHETER INTRODUCER USED WAS THE SMALLER SIZE 12.5."

  Patient problems: Apnea; Bradycardia

  MAUDE report 15431475 ↗