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SCANLAN® In Situ Valvulotomes
SCANLAN INTERNATIONAL INC · Model 9009-123 · UDI-DI 00846159010992
MGZ
Prescription
10
510(k) clearances
131
Adverse events
6
Recalls
13
Facilities
Description
Valvulotome
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | LimFlow, Inc. | Incorrect expiration date |
| 2023-07-13 | LeMaitre Vascular, Inc. | Burrs (molding flash) on the cutter may tear the harvested vien |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |
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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.