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.
31 linked reportsMalfunction 31
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.43 |
| 2019-02 | 0 | 5.57 |
| 2019-03 | 0 | 3.31 |
| 2019-04 | 0 | 3.13 |
| 2019-05 | 0 | 2.6 |
| 2019-06 | 0 | 3.19 |
| 2019-07 | 1 | 3.94 |
| 2019-08 | 4 | 4.13 |
| 2019-09 | 0 | 3 |
| 2019-10 | 2 | 2.79 |
| 2019-11 | 2 | 2.73 |
| 2019-12 | 0 | 2.76 |
| 2020-01 | 1 | 2.69 |
| 2020-02 | 0 | 1.75 |
| 2020-03 | 0 | 1.7 |
| 2020-04 | 0 | 1.75 |
| 2020-05 | 0 | 1.44 |
| 2020-06 | 0 | 1.39 |
| 2020-07 | 0 | 2.06 |
| 2020-08 | 1 | 1.48 |
| 2020-09 | 1 | 1.25 |
| 2020-10 | 0 | 3.06 |
| 2020-11 | 0 | 1.53 |
| 2020-12 | 0 | 1.79 |
| 2021-01 | 0 | 2.15 |
| 2021-02 | 0 | 2.22 |
| 2021-03 | 0 | 2.89 |
| 2021-04 | 0 | 2.47 |
| 2021-05 | 0 | 1.75 |
| 2021-06 | 0 | 2.65 |
| 2021-07 | 0 | 2.05 |
| 2021-08 | 0 | 1.6 |
| 2021-09 | 0 | 3.04 |
| 2021-10 | 0 | 1.78 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 2.58 |
| 2022-01 | 1 | 2.35 |
| 2022-02 | 0 | 2.82 |
| 2022-03 | 0 | 1.86 |
| 2022-04 | 0 | 2.11 |
| 2022-05 | 0 | 2.36 |
| 2022-06 | 0 | 2.92 |
| 2022-07 | 0 | 1.96 |
| 2022-08 | 0 | 2.1 |
| 2022-09 | 1 | 2.21 |
| 2022-10 | 1 | 2.57 |
| 2022-11 | 0 | 2.14 |
| 2022-12 | 0 | 3.13 |
| 2023-01 | 0 | 2.1 |
| 2023-02 | 0 | 2.17 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 2.35 |
| 2023-05 | 0 | 2.76 |
| 2023-06 | 0 | 2.36 |
| 2023-07 | 0 | 1.88 |
| 2023-08 | 0 | 1.79 |
| 2023-09 | 0 | 2.68 |
| 2023-10 | 0 | 1.94 |
| 2023-11 | 0 | 2.17 |
| 2023-12 | 0 | 2.35 |
| 2024-01 | 0 | 1.35 |
| 2024-02 | 1 | 1.86 |
| 2024-03 | 0 | 1.75 |
| 2024-04 | 0 | 2.04 |
| 2024-05 | 0 | 3.09 |
| 2024-06 | 0 | 1.91 |
| 2024-07 | 1 | 2.32 |
| 2024-08 | 0 | 3.94 |
| 2024-09 | 0 | 1.89 |
| 2024-10 | 0 | 2.06 |
| 2024-11 | 0 | 2.13 |
| 2024-12 | 0 | 2.76 |
| 2025-01 | 0 | 5.21 |
| 2025-02 | 2 | 3.16 |
| 2025-03 | 6 | 2.83 |
| 2025-04 | 0 | 3.91 |
| 2025-05 | 0 | 2.39 |
| 2025-06 | 0 | 4.94 |
| 2025-07 | 0 | 2.17 |
| 2025-08 | 0 | 3.29 |
| 2025-09 | 0 | 3.79 |
| 2025-10 | 0 | 3.14 |
| 2025-11 | 0 | 3.13 |
| 2025-12 | 0 | 3.77 |
| 2026-01 | 0 | 2.56 |
| 2026-02 | 0 | 8.61 |
| 2026-03 | 0 | 3.67 |
| 2026-04 | 0 | 3.26 |
| 2026-05 | 6 | 4.78 |
| 2026-06 | 0 | 2.43 |
Failure-mode summaryAI-generated
31 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2016-05-18 | Z-0289-2017 | Class II | Terminated | US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.Distribution: US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy. | 36 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-27 | 1528319-2026-00061 | Malfunction | Available | catalog number |
| 2026-05-14 | 1528319-2026-00048 | Malfunction | Available | catalog number |
| 2025-03-28 | 1528319-2025-00022 | Malfunction | Available | catalog number |
| 2025-03-08 | 1528319-2025-00015 | Malfunction | Available | catalog number |
| 2025-02-06 | 21321155 | Malfunction | Available | catalog number |
| 2024-07-11 | 1528319-2024-00056 | Malfunction | Available | exact di |
| 2024-02-15 | 1528319-2024-00011 | Malfunction | Available | exact di |
| 2022-10-20 | 1528319-2022-00053 | Malfunction | Available | exact di |
| 2022-09-02 | MW5111874 | Malfunction | Available | exact di |
| 2022-01-14 | 1528319-2022-00003 | Malfunction | Available | exact di |
| 2020-09-11 | 1528319-2020-00031 | Malfunction | Available | exact di |
| 2020-08-06 | 1528319-2020-00025 | Malfunction | Available | exact di |
| 2020-01-03 | 1528319-2020-00001 | Malfunction | Available | exact di |
| 2019-11-15 | 9327574 | Malfunction | Available | catalog number |
| 2019-10-23 | 1528319-2019-00039 | Malfunction | Available | exact di |
Showing the most recent 19 of 31 linked reports.
Showing 1–15 of 19
Regulatory clearances
- 510(k)K232826Substantially equivalent (SESE) · 2024-03-08clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
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