Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Check against the official notice below — it lists the full affected range.
Coloplast Manufacturing US, LLC has recalled the Titan Pump, a device used to treat erectile dysfunction in male patients, due to a potential increased occurrence of pump fracture over the lifetime of the device. Approximately 8,962 units were distributed worldwide and throughout the United States, as well as in Denmark, Spain, and Japan. The affected devices are identified by 149 lot or code numbers.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential increased occurrence of pump fracture over the lifetime of the device.
Reason for recall: Potential increased occurrence of pump fracture over the lifetime of the device. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP. Quantity: 8,962 units Lot/code info: 5585215, 5637061, 5887656, 5887660, 5887662, 6044855, 6121948, 6203696, 6256289, 6281814, 6282077, 6293595, 6340949, 6397321, 6450370, 6467920, 6523184, 6563685, 6565025, 6620080, 6625337, 6713215, 6741559, 6741597, 6759251, 6759252, 6778965, 6781635, 6828420, 6891543, 6891647, 6945902, 6949447, 6993341, 7023392, 7050985, 7051006, 7108209, 7109949, 7149995, 7150019, 7150020, 7180121, 7180122, 7261757, 7263766, 7263791, 7289306, 7299921, 7348362, 7356189, 7433677, 6408870, 6563692, 6942524, 6993351, 7045704, 7261764, 6408871, 6563693, 6942525, 6993352, 7045705, 7289317, 7338041, 5813224, 5817083, 5852938, 6050537, 6663007, 6778974, 6828426, 6949393, 6993357, 7150000, 7338043, 5813225, 5817084, 5852939, 6050538, 6337898, 6461064, 6563696, 6741565, 6778975, 6834142, 6883290, 6949394, 7007420, 7050992, 7150001, 7261766, 7289322, 7338044, 5736817, 6337896, 6523195, 6563694, 6945912, 6993353, 7045706, 7289318, 5584179, 6337897, 6523196, 6563695, 6945913, 6993354, 7045707, 7180852, 7261765, 7338042, 5742639, 5742640, 5758714, 5852940, 5907315, 6125002, 6620085, 6674084, 6741603, 6778976, 6828427, 6834143, 6993358, 7150002, 7180853, 5742641, 5742642, 5852941, 5907316, 6125003, 6563697, 6620086, 6741566, 6778977, 6828428, 6834144, 6883291, 7007421, 7150003, 7180854, 7261767, 5637052, 6337887, 6408865, 6563686, 6759253, 6993342, 7045695, 7289307, 7348363, 6121901, 6293550, 6337888, 6450603, 6523235, 6565026, 6625338, 6741560, 6778966, 6781636, 6837790, 6883286, 6949382, 7050965, 710809
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.