N/A (REF D5LT)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Dilating Tip Trocar w/Stability Sleeve · Class 2

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 00885825015619), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMay 13, 2026Break
IT WAS REPORTED THE TROCAR WAS IN SEPARATE PIECES INSIDE PACKAGING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164697 ↗

Device details

UDI-DI	`00885825015619`
Brand	N/A
Model	N/A
Catalog no.	D5LT
Company	Stryker Sustainability Solutions, Inc.
Product code	NLM · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 8, 2021

Device type (GMDN): Laparoscopic trocar blade, reprocessed

A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a previously used single-use device that has been processed for an additional single-use patient application.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.