Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 169–180 of 595 recalls
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss o…
Probes may rupture/burst during activation
Probes may rupture/burst during activation
Probes may rupture/burst during activation
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.