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American Medical Systems Recalls
6 recalls on record · November 14, 2012 to December 24, 2014 · Medical Devices
Recalls by year
12
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 24, 2014Medical DevicesFDA
American Medical Systems, Inc. recalls AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in
Hazard: 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 #
December 24, 2014Medical DevicesFDA
American Medical Systems, Inc. recalls AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning
Hazard: 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 #
November 19, 2014Medical DevicesFDA
American Medical Systems, Inc. recalls AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are p
Hazard: AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
May 22, 2013Medical DevicesFDA
American Medical Systems, Inc. recalls AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to re
Hazard: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
May 22, 2013Medical DevicesFDA
American Medical Systems, Inc. recalls AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to r
Hazard: American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
November 14, 2012Medical DevicesFDA
American Medical Systems, Inc. recalls AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System
Hazard: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the