Lower risk Medical device recall · FDA · Published March 1, 2023

Coloplast Titan Pump Assembly Recall: Risk of Premature Pump Failure

Coloplast recalls Titan Pump Assembly (Catalog 5177701400) due to potential premature pump failure from decreased wall thickness. Affected units include specific lot numbers for inflatable penile prostheses.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1360-2023Medical device Coloplast ›

Lower-risk recall

A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

Take action

Contact the company

Recalling firmColoplast Manufacturing US, LLC1601 W River Rd · Minneapolis, MN 55411-3431

✎ GovInfoNow plain-language explainer

Coloplast is recalling Titan Pump Assemblies (Catalog Number 5177701400) for inflatable penile prostheses. The recall is due to a potential risk of premature pump failure caused by reduced wall thickness in the pump assembly. Read more at govinfonow.com/recall/58801-coloplast-titan-pump-assembly-recall-risk-of-premature-pump-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/58801-coloplast-titan-pump-assembly-recall-risk-of-premature-pump-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1360-2023

Cite this page

“Coloplast Titan Pump Assembly Recall: Risk of Premature Pump Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58801-coloplast-titan-pump-assembly-recall-risk-of-premature-pump-failure. Based on FDA recall #Z-1360-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1360-2023%22&limit=1).

The FDA announced on March 1, 2023, that Coloplast Manufacturing US, LLC is recalling the Titan Pump Assembly for inflatable penile prostheses due to potential premature pump failure. The agency issued recall number Z-1360-2023 for the Class II voluntary recall.

How to tell if you have it

Brand: Coloplast
Product: Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
UDI/DI: 05708932319621
Lot Numbers: 8904177, 8849617

The hazard

According to the FDA, a decrease in wall thickness has the potential for a premature pump failure compared to a pump with standard wall thickness. This risk is based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

Context

GovInfoNow's records show Coloplast Manufacturing US, LLC has 4 other recalls on record since October 23, 2020. Other recent recalls include the Coloplast X-Flow Prostatectomy Catheter Recall (December 2, 2024) and the Coloplast Ureteral Dilator Recall (March 11, 2024). Similar recent recalls of other medical devices include the Medtronic Octopus Evolution Tissue Stabilizer Model TS2000 Recall (May 12, 2026) and the Olympus OER-ELITE Endoscope Reprocessor Tubes Recall (March 25, 2026).

How to tell if you have this one

Check for the Titan Pump Assembly with Catalog Number 5177701400. Affected units have lot numbers 8904177 or 8849617. The product is sold under UDI/DI 05708932319621.

Brand
Coloplast
Category
Medical device

FDA recall event · 17 products

All 17 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Recall number	Product, codes & lots	Quantity
Z-1359-2023	Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis; UDI/DI 05708932533966, Lot Numbers: 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, 8904186	18 units
Z-1360-2023	Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis; UDI/DI 05708932319621, Lot Numbers: 8904177, 8849617	9 units
Z-1361-2023	Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis; UDI/DI 05708932072519, Lot Numbers: 8887609	0
Z-1362-2023	Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis; UDI/DI 05708932072526, Lot Numbers: 8849570, 8904168, 8939114	7 units
Z-1363-2023	Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis; UDI/DI 05708932072557, Lot Numbers: 8840684	2 units
Z-1364-2023	Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis; UDI/DI 05708932072564, Lot Numbers: 8829594, 8849571, 8806760, 8840685	13 units
Z-1365-2023	Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis; UDI/DI 05708932072595, Lot Numbers: 8887620, 8939124	2 units
Z-1366-2023	Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis; UDI/DI 05708932072649, Lot Numbers: 8887622, 8965351	0
Z-1367-2023	Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis; UDI/DI 05708932539128, Lot Numbers: 8849582, 8849603, 8904185	15 units
Z-1368-2023	Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis; UDI/DI 05708932539142, Lot Numbers: 8849563, 8849585, 8904187	8 units
Z-1369-2023	Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis; UDI/DI 05708932539173, Lot Numbers: 8840677	1 unit
Z-1370-2023	Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis; UDI/DI 05708932539197, Lot Numbers: 8904188, 8806754, 8806755	20 units
Z-1371-2023	Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis; UDI/DI 05708932539203, Lot Numbers: 8806758, 8806757	11 units
Z-1372-2023	Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis; UDI/DI 05708932487245, Lot Numbers: 8849577, 8849578	22 units
Z-1373-2023	Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis; UDI/DI 05708932487344, Lot Numbers: 8849599, 8887865, 8939119, 8904178, 8904179	25 units
Z-1374-2023	Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis; UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621	20 units
Z-1375-2023	Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis; UDI/DI 05708932487382, Lot Numbers: 8849602, 8904182, 8840688, 8849622	23 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the Catalog Number 5177701400 and lot numbers 8904177 or 8849617 on your Titan Pump Assembly.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

Mar 1, 2023Firm started the recall
Apr 12, 2023FDA classified it Class II
Apr 19, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58801-coloplast-titan-pump-assembly-recall-risk-of-premature-pump-failure">Coloplast Titan Pump Assembly Recall: Risk of Premature Pump Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1360-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1360-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.