CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

AMS Monarc + Subfascial Hammock with Tensioning Suture recalled

American Medical Systems is recalling AMS Monarc + Subfascial Hammock with Tensioning Suture, distributed nationwide in the US. The recall was initiated on 15 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF 72404195 Lot/Serial 858296001 to 897413030; REF 72404193 Lot Serial 858292001 to 906172040

Quantity recalled2,165

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0805-2015
FDA event ID: 69796
Recalling firm: American Medical Systems, Minnetonka, MN
Classification: Class II
Status: Terminated
Recall initiated: 15 Oct 2014
FDA classified: 16 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

15 Oct 2014	Recall initiated by company
16 Dec 2014	Classified by FDA	+62 days
24 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.

Where it was distributed

Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

REF 72404195 Lot/Serial 858296001 to 897413030; REF 72404193 Lot Serial 858292001 to 906172040

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 69796

This product is part of a recall event; the main page for the event is AdVance"Male Sling System recalled by American Medical Systems.

Reported	Class	Recall	Company	Reason	Where
24 Dec 2014	CLASS II	AdVance"Male Sling System recalled by American Medical Systems	American Medical Systems	Sterility	Nationwide

More recalls from American Medical Systems

All 6

Reported	Class	Recall	Company	Reason	Where
24 Dec 2014Device	CLASS II	AdVance"Male Sling System recalled by American Medical Systems	American Medical Systems	Sterility	Nationwide
19 Nov 2014Device	CLASS II	AMS 700 Series Inflatable Penile Prosthesis Accessory Kit recalled	American Medical Systems	Other	Nationwide
22 May 2013Device	CLASS II	AMS 800¿ Urinary Control System recalled by American Medical Systems	American Medical Systems	Other	Nationwide
22 May 2013Device	CLASS II	AMS 800¿ Urinary Control System recalled by American Medical Systems	American Medical Systems	Other	Nationwide
14 Nov 2012Device	CLASS II	AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male recalled	American Medical Systems	Other	Nationwide

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All 3,809

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