Table 1. Characteristics of 510(k) Devices With Class I Recalls Between 2017-2021.
| No. (%) (n = 135) |
|
|---|---|
| Total No. of 510(k) Class I recall events | |
| 2021 | 24 (17.8) |
| 2020 | 21 (15.6) |
| 2019 | 36 (26.7) |
| 2018 | 24 (17.8) |
| 2017 | 30 (22.2) |
| No. of units recalled globally due to index device recall, median (IQR) | 9345 (887-174 655) |
| FDA-determined cause for recall | |
| Device or software design issue | 45 (33.3) |
| Process control issue | 21 (15.6) |
| Reason under investigation by firm | 20 (14.8) |
| Nonconforming material or component | 15 (11.1) |
| Component design or selection | 10 (7.4) |
| Component change control | 7 (5.2) |
| Use error | 4 (3.0) |
| Othera | 13 (9.6) |
| No. of unique 510(k) devices subject to Class I recalls | 156 |
| Regulation medical specialties | 130 |
| Cardiovascular | 46 (29.5) |
| Anesthesiology | 32 (20.5) |
| General hospital | 28 (18.0) |
| Neurology | 16 (10.3) |
| General and plastic surgery | 8 (5.1) |
| Most common product codes | |
| FRN (pump, infusion) | 11 (7.1) |
| HAW (neurological stereotaxic instrument) | 8 (5.1) |
| BZD (ventilator, noncontinuous, respirator) | 7 (4.5) |
| CBK (ventilator, continuous, facility use) | 7 (4.5) |
| DSP (system, balloon, intra-aortic and control) | 7 (4.5) |
| Special device designations | 156 |
| Life-sustaining or support device | 16 (10.3) |
| Implanted device | 11 (7.1) |
| Use of clinical data in 510(k) application | 156 |
| No clinical testing | 119 (76.3) |
| Information about device evidence unavailableb | 15 (9.6) |
| Insufficient information in decision memoc | 13 (8.3) |
| Included clinical data | 9 (5.8) |
| Recall history | |
| Time between clearance and recall of any class, median (IQR), y | 4.3 (1.6-10.7) |
| Time between clearance and first Class I recall, median (IQR), y | 7.3 (2.9-13.2) |
| No. of unique recalls per device, median (IQR) | 2 (1-4) |
| Subject to multiple recalls of any class | 86 (55.1) |
| Subject to multiple Class I recalls | 44 (28.2) |
a
Other reasons included unknown or determined by manufacturer, employee error, environmental control, labeling design, process change control, reprocessing controls, and software design.
b
No decision memo was posted for the index device in the Devices@FDA database, and as such, it was not possible to determine what, if any, premarket clinical testing was conducted.
c
Decision memo was available in the Devices@FDA database for the index device but did not state explicitly whether premarket clinical testing was conducted.