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Lumiflex
US Endoscopy · Model 00718006W · UDI-DI 00724995244668
1
510(k) clearances
5,224
Adverse events (16 deaths)
21
Recalls
59
Facilities
Description
LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/6mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-18 | Diversatek Healthcare | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. |
| 2026-03-18 | Diversatek Healthcare | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. |
| 2026-03-18 | Diversatek Healthcare | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. |
| 2026-03-18 | Diversatek Healthcare | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. |
| 2013-05-28 | Boston Scientific Corporation | Product labeled with incorrect expiration date. |
| 2007-04-16 | Conmed Endoscopic Technologies, Inc. | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| 2007-04-16 | Conmed Endoscopic Technologies, Inc. | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| 2007-04-16 | Conmed Endoscopic Technologies, Inc. | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| 2007-04-16 | Conmed Endoscopic Technologies, Inc. | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
| 2007-04-16 | Conmed Endoscopic Technologies, Inc. | Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator. |
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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.