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Z-MED™
B BRAUN INTERVENTIONAL SYSTEMS, INC · Model 610450 · UDI-DI 04046964328626
2
510(k) clearances
5,224
Adverse events (16 deaths)
21
Recalls
59
Facilities
Description
PDZ300 SPECIAL Z-MED 4X2X85
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.