Home › Coloplast A/S › Porges Coloplast
Porges Coloplast
Coloplast A/S · Model AJ4274 · UDI-DI 03600040198575
FAD
Prescription
10
510(k) clearances
5,967
Adverse events (9 deaths)
55
Recalls
70
Facilities
Description
Double loop ureteral stent in silicone open.open CH FR 07 length 26 cm with fixed core guidewire and connectable pusher
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | C.R. Bard Inc | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| 2025-11-06 | C.R. Bard Inc | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| 2025-11-06 | C.R. Bard Inc | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| 2025-11-06 | C.R. Bard Inc | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.