Stent, Ureteral
FDA adverse event reports and recall history for stent, ureteral (product code FAD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,821
- Deaths
- 9
- Injuries
- 1,665
- Malfunctions
- 4,104
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-11Open, ClassifiedUnder Investigation by firm
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2025-12-11Open, ClassifiedUnder Investigation by firm
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028
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 dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
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