Merit Medical Systems, Inc.DREClass II

Dilator, Vessel, For Percutaneous Catheterization

Merit Medical Systems, Inc.'s record for this product code

MDR events263All time

Recalls6All time

510(k) clearances10All time

Recent MDR events

263 adverse event reports on file

Recalls

6 recall events for this product code

Open, ClassifiedSep 20, 2024
7F sheath introducers labeled as 7.5F
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TerminatedJun 22, 2015
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
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TerminatedDec 14, 2009
Potential sterility breach caused by excessive shipment damage.
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TerminatedAug 4, 2004
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
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TerminatedAug 4, 2004
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
View FDA record ↗
TerminatedAug 4, 2004
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
View FDA record ↗

510(k) clearances

10 clearances for this product code