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.
108 linked reportsInjury 102Death 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.4 |
| 2019-02 | 0 | 1.29 |
| 2019-03 | 0 | 1.33 |
| 2019-04 | 0 | 2 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 2 | 1.25 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 1 |
| 2020-03 | 0 | 1.67 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 4 | 2.33 |
| 2021-07 | 0 | 1.4 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 2 | 1.2 |
| 2022-05 | 0 | 2.5 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 2 |
| 2022-10 | 4 | 2.67 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 1.67 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1 |
| 2023-06 | 1 | 1.5 |
| 2023-07 | 0 | 2 |
| 2023-09 | 1 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-02 | 1 | 1.5 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 1 | 1 |
| 2024-06 | 27 | 14.5 |
| 2024-07 | 15 | 15 |
| 2024-08 | 4 | 4.33 |
| 2024-09 | 0 | 9.5 |
| 2024-10 | 2 | 3.8 |
| 2024-11 | 2 | 2.33 |
| 2024-12 | 2 | 4.67 |
| 2025-01 | 2 | 2.33 |
| 2025-02 | 2 | 2 |
| 2025-03 | 1 | 1 |
| 2025-04 | 3 | 2 |
| 2025-05 | 3 | 4.33 |
| 2025-06 | 5 | 3 |
| 2025-07 | 2 | 3.67 |
| 2025-08 | 3 | 2 |
| 2025-09 | 4 | 2 |
| 2025-10 | 1 | 3.33 |
| 2025-11 | 3 | 2.67 |
| 2025-12 | 2 | 3.25 |
| 2026-01 | 1 | 1.5 |
| 2026-02 | 1 | 1 |
| 2026-03 | 5 | 5 |
| 2026-04 | 1 | 1.25 |
| 2026-05 | 0 | 1 |
| 2026-06 | 1 | 1.33 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-02-26 | Z-2536-2020 | Class II | Terminated | Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.Distribution: US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA. | 82 | clearance family |
| 2019-10-18 | Z-1827-2020 | Class II | Terminated | Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.Distribution: U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ. | 1882 | code info di |
| 2019-07-03 | Z-2073-2020 | Class II | Terminated | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.Distribution: US Nationwide distribution including in the states of FL, GA, NY, PA, and TX. | 44 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-30 | 3008062894-2026-00009 | Injury | Available | model number |
| 2026-04-30 | 3008062894-2026-00008 | Injury | Available | model number |
| 2026-03-20 | 3008062894-2026-00007 | Injury | Available | model number |
| 2026-03-20 | 3008062894-2026-00006 | Injury | Available | model number |
| 2026-03-12 | 3008062894-2026-00005 | Injury | Available | model number |
| 2026-03-03 | 3008062894-2026-00003 | Injury | Available | model number |
| 2026-03-03 | 3008062894-2026-00004 | Injury | Available | model number |
| 2026-02-23 | 3008062894-2026-00002 | Injury | Available | model number |
| 2026-01-08 | 3008062894-2026-00001 | Injury | Available | model number |
| 2025-12-23 | 3008062894-2025-00031 | Injury | Available | model number |
| 2025-12-05 | 3008062894-2025-00030 | Injury | Available | model number |
| 2025-11-25 | 3008062894-2025-00028 | Injury | Available | model number |
| 2025-11-25 | 3008062894-2025-00029 | Injury | Available | model number |
| 2025-11-04 | 3008062894-2025-00027 | Injury | Available | model number |
| 2025-10-07 | 3008062894-2025-00026 | Death | Available | model number |
Showing the most recent 102 of 108 linked reports.
Showing 1–15 of 102
Regulatory clearances
- 510(k)K192662Substantially equivalent (SESE) · 2020-02-14clearance family
- 510(k)K183192Substantially equivalent (SESE) · 2019-04-19clearance family
- 510(k)K161773Substantially equivalent (SESE) · 2016-10-21clearance family
Predicate lineage
K183192
Cited as predicate by: K192662
- K192662
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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