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Merit Advance®

Merit Medical Systems, Inc. · Model 00884450032015 · UDI-DI 00884450032015

DRC

510(k) clearances

1,994

Adverse events (59 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2024-03-01	Cook Incorporated	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
2021-10-08	Cook Inc.	Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used r
2021-01-19	Merit Medical Systems, Inc.	The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used,
2021-01-19	Merit Medical Systems, Inc.	The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used,
2019-02-01	Cook Inc.	The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
2018-03-12	CooperSurgical, Inc.	Products have been packaged with the wrong Trocar length type.
2016-03-15	Merit Medical Systems, Inc.	Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of t
2014-09-08	Instrumed International, Inc.	The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2013-09-13	CooperSurgical, Inc. D.B.A. Lone Star Medical Products	CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
2010-09-27	Ethicon Endo-Surgery Inc	This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially

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Data 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.