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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.83 |
| 2019-02 | 0 | 2.36 |
| 2019-03 | 0 | 1.67 |
| 2019-04 | 0 | 2.08 |
| 2019-05 | 0 | 1.82 |
| 2019-06 | 0 | 1.92 |
| 2019-07 | 0 | 2.21 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 2.14 |
| 2019-10 | 0 | 2.8 |
| 2019-11 | 0 | 2.67 |
| 2019-12 | 0 | 1.82 |
| 2020-01 | 0 | 2.24 |
| 2020-02 | 0 | 2.45 |
| 2020-03 | 0 | 1.58 |
| 2020-04 | 0 | 3.08 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 2.14 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 2.75 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 3.08 |
| 2020-11 | 0 | 3.08 |
| 2020-12 | 0 | 3.43 |
| 2021-01 | 0 | 1.78 |
| 2021-02 | 0 | 2.21 |
| 2021-03 | 0 | 3.43 |
| 2021-04 | 0 | 2.71 |
| 2021-05 | 0 | 2.8 |
| 2021-06 | 0 | 3.56 |
| 2021-07 | 0 | 3.57 |
| 2021-08 | 1 | 3.87 |
| 2021-09 | 0 | 2.5 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 2.9 |
| 2021-12 | 0 | 5.12 |
| 2022-01 | 0 | 2.75 |
| 2022-02 | 0 | 4.89 |
| 2022-03 | 0 | 5 |
| 2022-04 | 0 | 2.45 |
| 2022-05 | 0 | 2.08 |
| 2022-06 | 0 | 2.47 |
| 2022-07 | 0 | 2.53 |
| 2022-08 | 0 | 2.79 |
| 2022-09 | 0 | 5.21 |
| 2022-10 | 0 | 3.72 |
| 2022-11 | 0 | 7.1 |
| 2022-12 | 0 | 3.67 |
| 2023-01 | 0 | 2.83 |
| 2023-02 | 0 | 1.53 |
| 2023-03 | 0 | 5.33 |
| 2023-04 | 0 | 2.62 |
| 2023-05 | 0 | 5.13 |
| 2023-06 | 0 | 3.07 |
| 2023-07 | 0 | 4.25 |
| 2023-08 | 0 | 4.4 |
| 2023-09 | 0 | 6 |
| 2023-10 | 0 | 4.21 |
| 2023-11 | 0 | 3.47 |
| 2023-12 | 0 | 3.76 |
| 2024-01 | 0 | 2.86 |
| 2024-02 | 0 | 4.11 |
| 2024-03 | 0 | 3.43 |
| 2024-04 | 0 | 2.57 |
| 2024-05 | 0 | 4.3 |
| 2024-06 | 0 | 6.24 |
| 2024-07 | 0 | 10.05 |
| 2024-08 | 0 | 4.57 |
| 2024-09 | 0 | 5.06 |
| 2024-10 | 0 | 2.75 |
| 2024-11 | 0 | 4.17 |
| 2024-12 | 0 | 3.84 |
| 2025-01 | 0 | 4.45 |
| 2025-02 | 0 | 3.37 |
| 2025-03 | 0 | 7.28 |
| 2025-04 | 0 | 5.63 |
| 2025-05 | 0 | 3.61 |
| 2025-06 | 0 | 5.48 |
| 2025-07 | 0 | 7.56 |
| 2025-08 | 0 | 8.14 |
| 2025-09 | 0 | 4.84 |
| 2025-10 | 0 | 5.74 |
| 2025-11 | 0 | 3.91 |
| 2025-12 | 0 | 4.83 |
| 2026-01 | 0 | 6.83 |
| 2026-02 | 0 | 6.9 |
| 2026-03 | 0 | 5.46 |
| 2026-04 | 0 | 10.25 |
| 2026-05 | 0 | 4.11 |
| 2026-06 | 0 | 6.33 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-04-21 | Z-2382-2026 | Class I | Open, Classified | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. | 444,943 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-08-10 | 9680794-2021-00396 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-01-15 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-03-18 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2024-01-26 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2022-12-09 | NAI | No action indicated | Teleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company) | 0 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2022-08-26 | VAI | Voluntary action indicated | TELEFLEX LLC | 3 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-09-02 | NAI | No action indicated | TELEFLEX LLC | 0 |
| 2021-07-30 | VAI | Voluntary action indicated | Teleflex LLC (NADC) | 4 |
| 2017-09-21 | NAI | No action indicated | Teleflex LLC | 0 |
| 2017-09-20 | VAI | Voluntary action indicated | Teleflex Medical, Inc. | 1 |
| 2017-02-02 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-08-29 | NAI | No action indicated | Teleflex Medical OEM LLC | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2016-03-03 | NAI | No action indicated | Teleflex LLC (NADC) | 0 |
| 2015-08-13 | NAI | No action indicated | Teleflex Medical Sdn. Bhd. | 0 |
| 2015-06-05 | NAI | No action indicated | Teleflex Medical Europe Ltd | 0 |
| 2015-02-25 | NAI | No action indicated | Teleflex Medical Europe, Ltd. | 0 |
| 2014-08-28 | NAI | No action indicated | TELEFLEX LLC | 0 |
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