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DLP®
MEDTRONIC, INC. · Model 61000 · UDI-DI 20613994846604
1
510(k) clearances
2
Adverse events
5
Recalls
4
Facilities
Description
SET 61000 PRESSURE DISPLAY 45 10PK 17L
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-19 | Medtronic Perfusion Systems | Potential for unsealed sterile packing. |
| 2017-06-22 | Medtronic Perfusion Systems | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
| 2011-09-09 | Medtronic Perfusion Systems | The DFU for the Medtronic Pressure Display Box, model 66000, states that, for display readings of -100 to +300 mmHg there will be an accuracy of +/-5 mmHg, and for display readings |
| 2011-09-09 | Medtronic Perfusion Systems | Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedu |
| 2011-09-09 | Medtronic Perfusion Systems | Pressure Display Set (models 61000, 61006, 62000, 62006) DFU will be updated to clarify that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedu |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.