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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-01-22 | Z-1161-2021 | Class I | Terminated | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.Distribution: Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, FL, IL, KS, KY, LA, MD, MI, MO, NC, NJ, NY, OK, PA, RI, TN; In the countries of India, Italy, Japan, Poland, and United Arab Emirates. | 1185 units | clearance family |
Regulatory clearances
- 510(k)K193183Substantially equivalent (SESE) · 2020-03-20clearance 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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-02-28 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2022-02-28 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2019-03-04 | VAI | Voluntary action indicated | Acist Medical Systems | 1 |
| 2019-03-04 | VAI | Voluntary action indicated | Acist Medical Systems | 1 |
| 2016-03-01 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2016-03-01 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2012-06-06 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2012-06-06 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2010-03-24 | NAI | No action indicated | Acist Medical Systems | 0 |
| 2010-03-24 | NAI | No action indicated | Acist Medical Systems | 0 |
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