IMPERATIVE CARE INC
FDA Regulatory Profile
IMPERATIVE CARE INC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 17 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2577-2021, Class I) was initiated on August 13, 2021. Its most recent 510(k) clearance was granted on October 30, 2025.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 17
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2577-2021 | Class I | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 m | August 13, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252046 | Zoom System (Zoom 4S Catheter) | October 30, 2025 |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | August 28, 2025 |
| K244061 | X-Wire Guidewire | August 26, 2025 |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | May 28, 2025 |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | May 14, 2025 |
| K242672 | Zoom System | January 14, 2025 |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Sup | June 6, 2024 |
| K233975 | Zoom 6F Insert Catheters | April 2, 2024 |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Sup | May 22, 2023 |
| K220807 | Imperative Care Radial 088 Access System | May 17, 2022 |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | September 20, 2021 |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | June 8, 2021 |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | April 23, 2021 |
| K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform | March 3, 2021 |
| K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | September 2, 2020 |
| K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay | April 17, 2019 |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 | August 8, 2018 |