CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report

PreludeSNAP Splittable Hydrophilic recalled by Merit Medical Systems

Merit Medical Systems is recalling PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: Q1176348 Q1178762 Q1194660 Q1206565 Q1201803 Q1209475 Q1213042 Q1228339 Q1234189X1 Q1234639 Q1182862 Q1190097 Q1194661 Q1197055 Q1202959 Q1213024 Q1215467 Q1234979 Q1174112 Q1197331 Q1176349 Q1213048 Q1182863 Q1228338 Q1194041 Q1206577 Q1214620 Q1184987 Q1194664 Q1213051 Q1237072 Q1213018 Q1205118 Q1175815 Q1194665 Q1197054 Q1193985 Q1193397 Q1209478 Q1228340 Q1176347 Q1204708 Q1182836 Q1170938 Q1161477 Q1185050 Q1234958 Q1176345 Q1193391 Q1228356 Q1175817 Q1194663 Q1215702 Q1228354 Q1201789

Quantity recalled60,945 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0688-2018
FDA event ID: 78961
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2017
FDA classified: 22 Feb 2018
Reported: 28 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

14 Dec 2017	Recall initiated by company
22 Feb 2018	Classified by FDA	+70 days
28 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5

Where it was distributed

US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain

Questions about this recall

Why was it recalled?

Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

Which lots are affected?

Lot Numbers: Q1176348 Q1178762 Q1194660 Q1206565 Q1201803 Q1209475 Q1213042 Q1228339 Q1234189X1 Q1234639 Q1182862 Q1190097 Q1194661 Q1197055 Q1202959 Q1213024 Q1215467 Q1234979 Q1174112 Q1197331 Q1176349 Q1213048 Q1182863 Q1228338 Q1194041 Q1206577 Q1214620 Q1184987 Q1194664 Q1213051 Q1237072 Q1213018 Q1205118 Q1175815 Q1194665 Q1197054 Q1193985 Q1193397 Q1209478 Q1228340 Q1176347 Q1204708 Q1182836 Q1170938 Q1161477 Q1185050 Q1234958 Q1176345 Q1193391 Q1228356 Q1175817 Q1194663 Q1215702 Q1228354 Q1201789

Where was it sold?

US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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