Aspira® 00884450394861Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of Aspira (11)
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 00884450394861), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Recalls naming this device
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1599-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Cancer1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Use of Device Problem; Use of Device Problem
MEDWATCH REPORT WAS RECEIVED FROM THE FDA STATING: WITH SURGEON'S INSERTION OF AN ASPIRA CATHETER, THE COMPLEXITY OF THE SYSTEM CAUSED A RETAINED STYLET. PATIENT WITH LUNG CANCER AND MALIGNANT EFFUSIONS REQUIRING A CHEST CATHETER.
Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions
MAUDE report 23620060 ↗
Other APPARATUS, SUCTION, PATIENT CARE devices
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- PleurX 50-7500BCarefusion 2200, Inc · Apparatus, Suction, Patient Care66 reports
- Aspira® 00884450394946Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira® 00884450394915Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall2 reports
- Aspira Dressing Kit 4991503Bard Access Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394984Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450398173Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
- Aspira® 00884450394939Merit Medical Systems, Inc. · APPARATUS, SUCTION, PATIENT CARE1 recall0 reports
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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