Coloplast Manufacturing Us, Llc
1601 W River Rd N, MINNEAPOLIS, MN, US
Registered product codes
18 product codes
Recent MDR events
430 on file
- DEVICE, IMPOTENCE, MECHANICAL/HYDRAULICJun 10, 2026MalfunctionMW5189263
- DEVICE, IMPOTENCE, MECHANICAL/HYDRAULICJun 10, 2026MalfunctionMW5189264
- PENILE PROSTHESISJun 10, 2026MalfunctionMW5189268
- DEVICE, IMPOTENCE, MECHANICAL/HYDRAULICJun 3, 2026MalfunctionMW5188916
- TITAN INFLATABLE PENIS PROSTHESISJun 3, 2026MalfunctionMW5188917
- RESTORELLEApr 8, 2026InjuryMW5186466
- INFLATABLE PENILE PROSTHESISApr 8, 2026MalfunctionMW5186606
- INFLATABLE PENILE PROSTHESISMar 11, 2026MalfunctionMW5185111
- INFLATABLE PENILE PROSTHESISMar 11, 2026MalfunctionMW5185114
- ALTISMar 2, 2026Malfunction24477502
Recalls
34 on file
- Open, ClassifiedJan 10, 2025
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
View FDA record ↗ - Open, ClassifiedJan 10, 2025
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
View FDA record ↗ - Open, ClassifiedApr 2, 2024
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗ - Open, ClassifiedApr 12, 2023
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
View FDA record ↗
Compliance history
Matched by FEI 2125050.
FDA inspections
1 on file
- No Action Indicated (NAI)Mar 6, 2026
Bioresearch Monitoring
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.