FDA Device recall Z-0488-2021

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates…

FDA Device
Class II
terminated
Published 2020-12-02

On 2020-12-02 the FDA classified a Class II recall of Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates… by Coloplast Manufacturing Us, citing potential increased occurrence of pump fracture over the lifetime of the device.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0488-2021
Classification	Class II
Status	terminated
Initiated	2020-10-23
Published	2020-12-02
Last updated	2026-09-13 11:55 UTC
Company	Coloplast Manufacturing Us
Distribution	US

Product

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.

Reason

Potential increased occurrence of pump fracture over the lifetime of the device.

Identifiers

code_info	5585215, 5637061, 5887656, 5887660, 5887662, 6044855, 6121948, 6203696, 6256289, 6281814, 6282077, 6293595, 6340949, 63… 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, 7

code_info

5585215, 5637061, 5887656, 5887660, 5887662, 6044855, 6121948, 6203696, 6256289, 6281814, 6282077, 6293595, 6340949, 63…

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, 7

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0488-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.