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ImaJin
Coloplast A/S · Model AJ4871 · UDI-DI 05708932057745
FAD
Prescription
10
510(k) clearances
5,858
Adverse events (9 deaths)
55
Recalls
71
Facilities
Description
ImaJin ImaJin™. iso. Double loop ureteral stent kit. Length 16 cm, Catheter Gauge 7 FR/CH.
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 |
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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.