Spirit® Hydrocolloid Adhesive Sheath 35105Recalls & reported problems

C. R. Bard, Inc. · Spirit® Hydrocolloid Adhesive Sheath · Class 1

All models of Spirit Hydrocolloid Adhesive Sheath (28)

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

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 00801741070914), received between Nov 3, 2017 and Nov 3, 2017 — classified as 1 malfunction.

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

Most reported problems

Device problems

Device Operates Differently Than Expected1

Patient problems

No Information1

Recent adverse event reports

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

MalfunctionNov 3, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG.
Patient problems: No Information
MAUDE report 7000098 ↗

Device details

UDI-DI	`00801741070914`
Brand	Spirit® Hydrocolloid Adhesive Sheath
Model	35105
Company	C. R. Bard, Inc.
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	Jun 10, 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.

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

Spirit® Hydrocolloid Adhesive Sheath 39302
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
48 reports
Spirit® Hydrocolloid Adhesive Sheath 39303
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
42 reports
Spirit® Hydrocolloid Adhesive Sheath 35302
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
36 reports
Spirit® Hydrocolloid Adhesive Sheath 35303
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
32 reports
UltraFlex™ Self-Adhering Male External Catheter 33302
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
31 reports
Spirit® Hydrocolloid Adhesive Sheath 39304
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
29 reports
Wideband™ Self-Adhering Male External Catheter 36302
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
29 reports
Spirit® Hydrocolloid Adhesive Sheath 35304
C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
25 reports

All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE 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.

How reports and recalls are matched · Editorial policy · Report an error on this page