Merit Pursue™ 00884450358733Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit Pursue (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450358733), received between May 30, 2023 and May 30, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 6, 2023Class IIOpen, Classified
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Z-0628-2024 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A PAE PROCEDURE AND DURING AN OVER-THE-WIRE EXCHANGE, THE CATHETER WAS PULLED BACK AND THE RADIOPAQUE MARKER BROKE OFF THE TIP. THE PHYSICIAN LEFT IT IN THE PATIENT WITH NO PLANS TO REMOVE. THE PROCEDURE WAS FINISHED WITH A NEW DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 17027803 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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