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Brainlab Flexible Catheter
Brainlab SE · Model 19771 · UDI-DI 04056481006433
1
510(k) clearances
157
Adverse events (4 deaths)
6
Recalls
19
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-17 | Integra LifeSciences Corp. | Incorrect labeling, Catheter did not have the required holes and markings |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2004-03-11 | Codman & Shurtleff, Inc. | Drainage tips absent from catheter tip |
| 2003-03-19 | Integra Life Sciences Corp. | The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottl |
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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.