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MEDTRONIC, INC. · Model 1A63R11 · UDI-DI 00643169178014
DWE
Prescription
1
510(k) clearances
1,866
Adverse events (81 deaths)
48
Recalls
20
Facilities
Description
CUSTOM PACK 1A63R11 E INFANT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-07-03 | LivaNova USA Inc. | Perfusion tubing pack was packaged with the incorrect cuvette. |
| 2017-12-19 | LivaNova USA | The product is labeled with the incorrect expiration date. |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-10-19 | Datascope Corporation | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and |
| 2017-07-27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. |
| 2017-07-27 | Datascope Corporation | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. |
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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.