Q'APEL MEDICAL LLC
62 adverse events · 7 clearances · 2 inspections · 1 compliance actions · 1 recalls · aggregated across 3 source records
Scorecard
Events per device across the 32-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.78 ▼
25 in the last 12 months
Higher volume than 97% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
32 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Zebra | AC7087-095-20-S | DQY | 00857545008219 | 17 |
| Zebra | AC7087-095-20-B | DQY | 00857545008233 | 13 |
| Walrus | FG 00100-02 | DQY MJN | 00857545008028 | 11 |
| 072 Aspiration System | FG 00806 | NRY | 00857545008097 | 9 |
| Zebra | AC7087-105-20-S | DQY | 00857545008226 | 6 |
| Wahoo | FG 00074 | DQY | 00857545008004 | 5 |
| Zebra | AC6074-095-30 | DQY | 00857545008158 | 5 |
| Zebra | AC6074-095-20 | DQY | 00857545008189 | 4 |
| 072 Aspiration System | FG 01252 | NRY | 00857545008127 | 3 |
| 072 Aspiration System | FG 00995 | NRY | 00857545008103 | 3 |
| Armadillo | FG 00464-07 | DQY QJP | 00857545008066 | 3 |
| Walrus | FG 00100-01 | DQY MJN | 00857545008011 | 2 |
| Zebra | AC7087-105-20-B | DQY | 00857545008240 | 2 |
| 6F Armadillo | FG 00735-05 | DQY QJP | 00857545008080 | 1 |
| 087 BALLOON GUIDE CATHETER SYSTEM | 0 | |||
| Armadillo | FG 00464-05 | DQY QJP | 00857545008042 | 0 |
| Armadillo | FG 00464-08 | DQY QJP | 00857545008073 | 0 |
| Armadillo | FG 00464-04 | DQY QJP | 00857545008059 | 0 |
| SELECTFLEX II 072 NEUROVASCULAR ACCESS SYSTEM | 0 | |||
| ZEBRA NEUROVASCULAR ACCESS CATHETER | 0 | |||
| Zebra | AC6074-105-30 | DQY | 00857545008165 | 0 |
| Zebra | AC6074-105-20 | DQY | 00857545008196 | 0 |
| Zebra | AC7087-095 | DQY | 00857545008431 | 0 |
| Zebra | AC7087-105 | DQY | 00857545008448 | 0 |
| Zebra | AC6074-105 | DQY | 00857545008400 | 0 |
| Zebra | AC6074-115-30 | DQY | 00857545008172 | 0 |
| Zebra | AC6074-115-20 | DQY | 00857545008202 | 0 |
| Zebra | AC6074-080-30 | DQY | 00857545008257 | 0 |
| Zebra | AC6074-080-20 | DQY | 00857545008264 | 0 |
| Zebra | AC7087-080-20-B | DQY | 00857545008288 | 0 |
Showing 1–30 of 32Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2025-02-05 | WL | Warning Letter | Q'apel Medical, Inc. |
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3020954126 | Q'apel Medical, Inc. | Fremont, CA, US | OAI |