Merit Medical recalls specific PreludeSNAP Splittable Sheath Introducers due to intermittent splittable hub failure. Affected models include PLS-1007 to PLSX-1009.5 with certain lot numbers. Consumers should contact Merit Medical for details.
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.
Merit Medical is recalling specific lots of PreludeSNAP Splittable Sheath Introducers because the splittable hub can fail intermittently. This could lead to device malfunction during medical procedures, potentially causing complications for patients.
The splittable hub in these devices can fail intermittently, meaning it may not properly separate or stay in place during use. This could cause the device to malfunction during medical procedures, potentially leading to complications for patients.
Healthcare professionals using these specific sheath introducers in medical procedures are most at risk. Patients undergoing procedures with affected devices may experience complications.
Check the catalog numbers on the device: 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. Also check the lot numbers listed in the recall notice.
Look for the catalog number on the device to confirm if it is affected by this recall.
Reach out to Merit Medical Systems, Inc. for specific instructions on how to handle the recalled device.
The affected models include PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers with catalog numbers PLS-1007 through PLSX-1009.5.
Contact Merit Medical Systems, Inc. directly for instructions on how to handle the recalled device.
The recall states there is an intermittent failure of the splittable hub, which could lead to device malfunction during medical procedures, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0688-2018 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0688-2018 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
