ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Reported: June 28, 2023 Initiated: May 10, 2023 #Z-1723-2023
Product Description
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Reason for Recall
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 22,114 units
- Distribution
- US Nationwide - Worldwide Distribution
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 22,114 units.
Why was this product recalled? ▼
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2023. Severity: Critical. Recall number: Z-1723-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11