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HeartSpan®
Merit Medical · Model 00884450451663 · UDI-DI 00884450451663
10
510(k) clearances
1,994
Adverse events (59 deaths)
11
Recalls
94
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| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a |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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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.