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.
25 linked reportsMalfunction 17Injury 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.64 |
| 2019-02 | 0 | 1.52 |
| 2019-03 | 0 | 1.78 |
| 2019-04 | 0 | 1.69 |
| 2019-05 | 0 | 1.69 |
| 2019-06 | 0 | 1.57 |
| 2019-07 | 0 | 2.02 |
| 2019-08 | 0 | 2.38 |
| 2019-09 | 0 | 2.08 |
| 2019-10 | 0 | 2.24 |
| 2019-11 | 0 | 2.03 |
| 2019-12 | 0 | 2.52 |
| 2020-01 | 0 | 2.3 |
| 2020-02 | 0 | 2.95 |
| 2020-03 | 0 | 2.85 |
| 2020-04 | 0 | 2.16 |
| 2020-05 | 0 | 2.68 |
| 2020-06 | 0 | 2.49 |
| 2020-07 | 0 | 2.84 |
| 2020-08 | 0 | 2.54 |
| 2020-09 | 0 | 2.44 |
| 2020-10 | 0 | 2.65 |
| 2020-11 | 0 | 2.68 |
| 2020-12 | 0 | 2.75 |
| 2021-01 | 0 | 3.03 |
| 2021-02 | 0 | 2.16 |
| 2021-03 | 0 | 2.69 |
| 2021-04 | 0 | 2.62 |
| 2021-05 | 0 | 2.05 |
| 2021-06 | 0 | 2.42 |
| 2021-07 | 0 | 3.07 |
| 2021-08 | 0 | 2.39 |
| 2021-09 | 0 | 2.41 |
| 2021-10 | 0 | 2.02 |
| 2021-11 | 0 | 2.34 |
| 2021-12 | 0 | 2.64 |
| 2022-01 | 0 | 2.63 |
| 2022-02 | 0 | 2.35 |
| 2022-03 | 0 | 2.36 |
| 2022-04 | 0 | 2.61 |
| 2022-05 | 0 | 2.86 |
| 2022-06 | 0 | 2.75 |
| 2022-07 | 0 | 2.57 |
| 2022-08 | 0 | 3.01 |
| 2022-09 | 0 | 2.56 |
| 2022-10 | 0 | 2.26 |
| 2022-11 | 0 | 2.62 |
| 2022-12 | 0 | 2.42 |
| 2023-01 | 0 | 1.86 |
| 2023-02 | 0 | 2.64 |
| 2023-03 | 0 | 2.56 |
| 2023-04 | 3 | 2.25 |
| 2023-05 | 0 | 2.99 |
| 2023-06 | 0 | 2.39 |
| 2023-07 | 0 | 2.63 |
| 2023-08 | 0 | 2.65 |
| 2023-09 | 0 | 2.76 |
| 2023-10 | 0 | 2.54 |
| 2023-11 | 0 | 2.64 |
| 2023-12 | 2 | 2.8 |
| 2024-01 | 0 | 2.65 |
| 2024-02 | 0 | 2.63 |
| 2024-03 | 0 | 2.81 |
| 2024-04 | 0 | 2.26 |
| 2024-05 | 0 | 3.29 |
| 2024-06 | 0 | 3.05 |
| 2024-07 | 0 | 2.31 |
| 2024-08 | 0 | 3.62 |
| 2024-09 | 3 | 3.04 |
| 2024-10 | 0 | 4.01 |
| 2024-11 | 0 | 3.37 |
| 2024-12 | 0 | 3.81 |
| 2025-01 | 8 | 2.98 |
| 2025-02 | 0 | 3.19 |
| 2025-03 | 0 | 3.22 |
| 2025-04 | 0 | 3.49 |
| 2025-05 | 0 | 3.33 |
| 2025-06 | 0 | 2.89 |
| 2025-07 | 0 | 3.12 |
| 2025-08 | 0 | 3.21 |
| 2025-09 | 0 | 3.5 |
| 2025-10 | 0 | 3.24 |
| 2025-11 | 0 | 3.94 |
| 2025-12 | 0 | 4.49 |
| 2026-01 | 3 | 3.58 |
| 2026-02 | 0 | 3.79 |
| 2026-03 | 0 | 3.9 |
| 2026-04 | 0 | 2.99 |
| 2026-05 | 6 | 2.69 |
| 2026-06 | 0 | 2.84 |
Failure-mode summaryAI-generated
25 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2011-01-07 | Z-2791-2011 | Terminated | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization. | — | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-26 | 2024168-2026-02139 | Malfunction | Available | catalog number |
| 2026-05-26 | 2024168-2026-02140 | Malfunction | Available | catalog number |
| 2026-01-28 | 2024168-2026-00379 | Malfunction | Available | catalog number |
| 2025-01-02 | 2024168-2025-00002 | Injury | Available | catalog number |
| 2025-01-02 | 2024168-2025-00003 | Injury | Available | catalog number |
| 2025-01-02 | 2024168-2025-00001 | Injury | Available | catalog number |
| 2025-01-02 | 2024168-2025-00004 | Injury | Available | catalog number |
| 2024-09-06 | 2024168-2024-10536 | Malfunction | Available | catalog number |
| 2023-12-06 | 2024168-2023-13559 | Malfunction | Available | catalog number |
| 2023-04-28 | 2024168-2023-04458 | Malfunction | Available | catalog number |
Showing the most recent 10 of 25 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-12-08 | NAI | No action indicated | Abbott Vascular | 0 |
| 2023-11-16 | OAI | Official action indicated | Abbott Vascular | 0 |
| 2023-10-27 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2022-08-23 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2021-11-03 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2019-10-24 | NAI | No action indicated | Abbott Vascular | 0 |
| 2017-11-15 | VAI | Voluntary action indicated | Abbott Vascular | 2 |
| 2017-10-10 | NAI | No action indicated | Abbott Vascular | 0 |
| 2017-10-04 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2016-12-09 | NAI | No action indicated | Abbott Vascular | 0 |
| 2016-04-15 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2015-12-10 | NAI | No action indicated | Abbott Vascular | 0 |
| 2015-09-11 | NAI | No action indicated | Abbott Vascular | 0 |
| 2015-08-14 | NAI | No action indicated | Abbott Vascular, Inc. | 0 |
| 2015-07-23 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-11-24 | NAI | No action indicated | Abbott Vascular Inc | 0 |
| 2014-08-21 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-03-14 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-02-19 | NAI | No action indicated | Abbott Vascular | 0 |
| 2014-02-11 | VAI | Voluntary action indicated | Abbott Vascular Inc | 3 |
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