Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-02-26 | Z-1512-2025 | Class I | Open, Classified | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.Distribution: US: CA, IL, NE, TN, TX, NJ, NC, SD, FL, MI, PA, GA, AL, IN, NY, WI, AZ, MN, LA, OH, OK, SC, NV, ND, ID, MO, CT, WA, MA. OUS: QATAR, United Arab Emirates, Republic of Kazakhstan | 1617 | code info di |
Regulatory clearances
- 510(k)K222786Substantially equivalent (SESE) · 2023-08-25clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-05 | WL | Warning Letter | Q'apel Medical, Inc. | — |
| 2024-08-08 | OAI | Official action indicated | Qapel Medical Inc. | 7 |
| 2022-03-08 | VAI | Voluntary action indicated | Q'apel Medical, Inc. | 2 |