NAMIC 64037107Recalls & reported problems
Medline Industries, Inc. · MANIFOLD 1 VALVE PERC HP RH/OFF PG · Class 2
Data updated Oct 13, 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 24, 2026Open, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2141-2026 · Root cause: Under Investigation by firm · FDA record ↗
Other Transducer, blood-pressure, extravascular devices
- Acumen IQ AIQS85Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall7 reports
- ACUMEN IQ SENSOR AIQS6AZ5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8R5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS65Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- NAMIC 70036160Medline Industries, Inc. · Transducer, blood-pressure, extravascular1 recall0 reports
- Acumen IQ AIQS6REdwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6R5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page