Medline ReNewal IUB5LTRHRecalls & reported problems

Medline Industries, Inc. · B5LT @ENDPH XCEL BLADELESS TROCAR, W/STA · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277381070), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Break1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

InjuryApr 23, 2018Break
IT WAS REPORTED THAT THE CLEAR PLASTIC TIP OF A REPROCESSED ETHICON B5LT 5MM TROCAR BROKE.
Patient problems: Foreign Body In Patient
MAUDE report 7450333 ↗

Device details

UDI-DI	`10888277381070`
Brand	Medline ReNewal
Model	IUB5LTRH
Company	Medline Industries, 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 It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity.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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All LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED devices →

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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