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CAVH Catheter
Medical Components, Inc. · Model TRAY #632 · UDI-DI 00884908055894
LFK
Prescription
10
510(k) clearances
42
Adverse events (3 deaths)
7
Recalls
6
Facilities
Description
8F X 6" CAVH CATHETER TRAY
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-15 | Cook Inc. | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a devi |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
| 2008-09-08 | ConMed Corporation | The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It was also noted that the incidence of the forward cup slipping off the sh |
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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.