InView Standard 97532Recalls & reported problems

Hollister Incorporated · Male Incontinence Catheter, Self-Adhesive · Class 1

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 00610075975327), received between Sep 23, 2026 and Sep 23, 2026.

The most frequently reported specific device problem is “Adhesive Too Strong” (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

Adhesive Too Strong1
Patient-Device Incompatibility1

Patient problems

Skin Inflammation/ Irritation1

Recent adverse event reports

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

OtherSep 23, 2026Patient-Device Incompatibility; Adhesive Too Strong
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50873299 ↗

Device details

UDI-DI	`00610075975327`
Brand	InView Standard
Model	97532
Company	Hollister Incorporated
Product code	NNX · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 9, 2022

Device type (GMDN): Urinary incontinence penis sheath/port, single-use

A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

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All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices →

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