510(k) · Cleared

Recalled · Class II · 2018

Hemashield Knitted Double Velour Cardiovascular Fabric

K955349510(k) TraditionalCleared Feb 14, 199685-day reviewClass II21 CFR 870.3470Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Meadox Medicals, Div. Boston Scientific Corp. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Feb 14, 1996 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.

Decided: Feb 14, 1996
Review: 85 days
Class: Class II
Product code: DXZ
Recalls: 2
Predicates: 0

4 later devices descend from it, 1 citing it directly.

This deviceK955349 Hemashield Knitted Double Velour Cardiovascular FabricMeadox Medicals, Div. Boston Scientific Corp. · 1996
Descendant · cites it directly · 3 of its ownK962342 Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
Descendant · 2 generations on · 1 of its ownK112683 Smi Cardiovascular PachSolimas Medical, Inc. · 2011
Descendant · 3 generations on · 0 of its ownK122105 Smi Cardiovascular PatchSolinas Medical, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK101740 Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010

Most influential descendants

Showing 4 of 4 · See all

K962342Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly3descendants
K112683Smi Cardiovascular PachSolimas Medical, Inc. · 2011 · 2 generations on1descendant
K122105Smi Cardiovascular PatchSolinas Medical, Inc. · 2012 · 3 generations on0descendants
K101740Albosure Polyester Vascular PatchLeMaitre Vascular, Inc. · 2010 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K955349	Hemashield Knitted Double Velour Cardiovascular Fabric	Meadox Medicals, Div. Boston Scientific Corp.	1996	—
+1	K962342	Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch	Meadox Medicals, Div. Boston Scientific Corp.	1996	2
+2	K112683	Smi Cardiovascular Pach	Solimas Medical, Inc.	2011	—
+3	K122105	Smi Cardiovascular Patch	Solinas Medical, Inc.	2012	—
+2	K101740	Albosure Polyester Vascular Patch	LeMaitre Vascular, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2010	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K955349, 1996–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXZ device

#1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
#2 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962342	Hemashield Finesse Ultra-Thin, Knitted Cardiovascular Patch	Meadox Medicals, Div. Boston Scientific Corp.	1996	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 3, 2018	Class II	Z-1172-2018	Labeling mix-ups	A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
May 24, 2010	Not classified	Z-2062-2010	Package design/selection	Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K962342 (Meadox Medicals, Div. Boston Scientific Corp., 1996) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXZ

1in 2025

2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	50
2008	2	—	0	6
2009	1	—	0	109
2010	3	91	2	81
2011	2	—	2	47
2012	1	—	0	21
2013	1	—	2	69
2014	3	106	0	93
2015	2	—	0	171
2016	2	—	0	66
2017	1	—	0	30
2018	0	—	1	44
2019	0	—	0	55
2020	1	—	1	121
2021	0	—	0	80
2022	0	—	0	77
2023	0	—	2	40
2024	0	—	0	49
2025	1	—	2 (2)	119
2026	0	—	1	—

https://510kreport.com/device/K955349 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955349: Hemashield Knitted Double Velour Cardiovascular Fabric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955349

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026