Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 19, 2017
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may ent…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merit Medical Systems, Inc. recalled The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used… - a moderate-severity action.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used… was recalled by Merit Medical Systems, Inc. in April 19, 2017. Reason: Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device …. Check the official notice for the remedy. Verify recall #Z-1766-2017 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device ….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- April 19, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1766-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1766-2017) was formally reported on April 19, 2017, with the manufacturer initiating the action on March 3, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 1,940 units total.
The documented reason for this recall is: Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal… Distribution data in the federal record shows the product reached: Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,940 units total
Related Recalls
6
3 from same agency
Product description
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1766-2017 |
| Date reported | April 19, 2017 |
| Date initiated | March 3, 2017 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | South Jordan, UT |
| Affected scope | 1,940 units total |
| Distribution | Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1766-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.. Recalled by Merit Medical Systems, Inc.. Units affected: 1,940 units total.
Why was this product recalled? ▼
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1766-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide, Canadian and other foreign consignees. No VA/govt/military consignees..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1766-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 19, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.