Home › IMPERATIVE CARE, INC. › Prodigy™ Catheter
Prodigy™ Catheter
IMPERATIVE CARE, INC. · Model PRODIGY5F · UDI-DI 08500320790046
QEW
Prescription
1
510(k) clearances
1,318
Adverse events (128 deaths)
10
Recalls
72
Facilities
Description
5F Prodigy™ Catheter Length: 160 cm Inner Diameter: 0.055 in Outer Diameter: 0.067 in (1.70 mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-08 | Inari Medical - Oak Canyon | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally incr |
| 2024-07-19 | Inari Medical - Oak Canyon | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected |
| 2024-05-01 | Mermaid Medical A/S | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
| 2022-01-11 | TELEFLEX MEDICAL INC | The firm received reports indicating PTD tip separation during use. |
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.