Transducer, Blood-Pressure, Extravascular
FDA adverse event reports and recall history for transducer, blood-pressure, extravascular (product code DRS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,890
- Deaths
- 25
- Injuries
- 250
- Malfunctions
- 3,481
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-08Open, ClassifiedUnder Investigation by firm
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- 2026-05-08Open, ClassifiedUnder Investigation by firm
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
- 2025-03-21Open, ClassifiedProcess change control
namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
Medex LOGICAL CATH LAB KIT, List Number M20754
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
6IN PRESSURE TUBING, List Number MX20617
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
- 2024-01-17Open, ClassifiedNonconforming Material/Component
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Monitor transducer, blood-pressure, extravascular automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.