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.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- October 23, 2020
- Terminated
- May 13, 2021
- Recall Number
- Z-0488-2021
- Quantity
- 8,962 units
- Firm Location
- Minneapolis, MN
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.
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, 7108091, 7261758, 7289308, 7348364, 5493118, 5584171, 5585228, 5616471, 5953308, 6000536, 6046592, 6121902, 6203655, 6256291, 6257005, 6287824, 6287825, 6293551, 6293552, 6337889, 6401124, 6401857, 6408866, 6450604, 6450605, 6461060, 6523185, 6523236, 6563687, 6565095, 6625339, 6625389, 6674051, 6741561, 6741631, 6741632, 6778967, 6781616, 6781637, 6837840, 6837841, 6883287, 6886577, 6945903, 6949383, 7045696, 7050966, 7108122, 7108210, 7150021, 7150022, 7180870, 7180892, 7263767, 7289309, 7299972, 7348365, 7356190, 7432367, 7432368, 5585205, 5637053, 5673510, 5748875, 5817200, 5817206, 5923738, 5953309, 5954002, 6000537, 6046593, 6121903, 6157434, 6203656, 6203657, 6203725, 6203726, 6256292, 6257006, 6287826, 6293553, 6337890, 6340891, 6401125, 6401858 ,6401885, 6461061, 6467921, 6523186, 6523237, 6526312, 6565096, 6565097, 6565133, 6625340, 6625390, 6662998, 6674247, 6674289, 6715292, 6741598, 6741633, 6778968, 6781617, 6828421, 6834138, 6837791, 6837842, 6883288, 6891544, 6891649, 6945904, 6949384, 6993343, 7007443, 7045697, 7050986, 7051007, 7108092, 7108123, 7108211, 7149996, 7150023, 7180871, 7180893, 7263768, 7263792, 7289310, 7299973, 7348366, 7356435, 7432369, 7432370, 7432371, 5493073, 5585206, 5637054, 5637137, 5817253, 5953310, 5988740, 6046594, 6121904, 6157435, 6203658, 6247927, 6256293, 6287827, 6293554, 6340892, 6401126, 6401859, 6450606, 6450607, 6523187, 6565027, 6565098, 6565099, 6565134, 6565135, 6625341, 6674248, 6741562, 6741599, 6741634, 6759254, 6781592, 6781638, 6828422, 6949385, 6949386, 6949448, 6993344, 7007415, 7007444, 7012748, 7045698, 7108093, 7108094, 7108124, 7150024, 7150025, 7180872, 7263769, 7299901, 7299902, 7338036, 7348367, 7432372, 5584172, 6293585, 6563688, 6741635, 6759255, 6786417, 6993345, 7045699, 7289311, 7348368, 5585207, 5585208, 5860331, 5953311, 5953965, 5988741, 6046595, 6247928, 6337891, 6388057, 6401860, 6523188, 6526313, 6563689, 6565100, 6625342, 6663000, 6674052, 6741563, 6837792, 6886579, 6945905, 7007416, 7050967, 7108095, 7180873, 7263770, 5493076, 5585210, 5585231, 5585232, 5616472, 5637057, 5673512, 5748877, 5748878, 5852948, 5953313, 5953314, 6000539, 6046600, 6046671, 6121906, 6121950, 6125000, 6157438, 6203662, 6203698, 6247933, 6256295, 6257010, 6287830, 6293558, 6293559, 6337895, 6340896, 6401129, 6401862, 6408869, 6450609, 6461063, 6523192, 6523240, 6526318, 6565031, 6565139, 6565140, 6625344, 6625394, 6674055, 6674251, 6674292, 6713220, 6726455, 6741602, 6759257, 6781595, 6781596, 6781619, 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7180896, 7263775, 7263776, 7263795, 7263796, 7263797, 7289314, 7299904, 7299977, 7299978, 73380387348370, 7356438, 7432376, 5622572, 5491299, 5585227, 5491300, 5531593, 5531594, 5531595, 5531596, 5584161.
Root Cause
Component design/selection
Action Taken
Required Action Coloplast asks that you please do the following: 1. Immediately move all inventory (purchased directly or that may be stocked as consignment inventory) to quarantine, and return all Titan pump product (as identified in this notification) to Coloplast within 10 business days of receiving this letter. Product return instructions are located at the end of the attached Acknowledgement and Receipt Form. If you have further distributed this product, please notify your customers at once of this recall. 2. Complete the attached Acknowledgement and Receipt Form indicating the quantity that will be returned. If you do not have pumps to return, please denote that on the form. Please ensure you fill in your contact information. 3. Forward the completed form to the Coloplast contact information found at the bottom of the acknowledgement form. If you have further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.