RUSCH IPN053441Recalls & reported problems

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

Feb 27, 2019Terminated
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
Z-0797-2020 · Root cause: Under Investigation by firm · FDA record ↗

Device details

UDI-DI	`24026704549843`
Brand	RUSCH
Model	IPN053441
Catalog no.	A1500M
Company	Teleflex Incorporated
Product code	NNY · SHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2026

Device type (GMDN): Indwelling urethral drainage balloon catheter, non-antimicrobial

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Other SHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE devices

RUSCH IPN053440
Teleflex Incorporated · SHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE
1 recall0 reports

All SHEATH, CORRUGATED RUBBER, FOR NON-INDWELLING CATHETER, NON-STERILE devices →

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