Class IIOngoingZ-0772-2025
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG…
Software issues were identified in application version 2.x.
Medtronic Neuromodulat…MNJan 8, 2025
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,117–1,121 of 1,121 recalls
Class IIOngoingZ-0771-2025
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG…
Software issues were identified in application version 2.x.
Medtronic Neuromodulat…MNJan 8, 2025
Class IIOngoingZ-0770-2025
Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Angiodynamics, Inc.NYJan 8, 2025
Class IIOngoingZ-0769-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
- Uncemented Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis
- Under Investigation by firm
Waldemar Link GmbH & C…Jan 1, 2025
Class IIOngoingZ-0753-2025
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the final…
Abbott MedicalCAJan 1, 2025