Terminated

AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

FDA Recall Z-2669-2011 · Posted 2011-06-27

Recalling FirmAmerican Medical Systems, Inc.

Recall StatusTerminated

Product CodeEZY

Date Initiated2011-05-09

Date Terminated2012-07-06

Product Quantity15,466

Reason for Recall

American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa

Firm Action

American Medical System sent an "URGENT MEDICAL DEVICE RECALL letter dated May 9, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer Customers were instructed to return any existing stock . Please contact American Medical System at 1 (800) 328-3881 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product. For further questions please contact American Medical Systems at 1- (800)328-3881.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BELGIUM NETHERLANDS, PERU, VENEZUELA, SRI LANKA, PORTUGAL, TUKEY, BRAZIL AUSTRALIA, CZECH REPUBLIC, TUNISIA. LUXWMBOURG, QATAR, SOLOMON ISLANDS, BOSNIA & HERZEGOVIA, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, ECUADOR, ESTONIA, FINLAND, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, POLND, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SLOVENIA, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM and URUGUAY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.