Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-1650-2021

Z-1650-2021 Class II Terminated

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN

FDA device recall Z-1650-2021 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on April 7, 2021 and is designated Class II. Reason for recall: The device may contain a manufacturing defect of a missing resistance spot weld (RSW). The recall status is terminated (terminated August 23, 2024). Affected quantity: 2 units.

Recall Details

Product Type
Devices
Report Date
May 26, 2021
Initiation Date
April 7, 2021
Termination Date
August 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.

Reason for Recall

The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

Distribution Pattern

US Nationwide distribution in the state of North Carolina.

Code Information

Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S

Other recalls by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

  • Z-1805-2023 Class I — ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardi (May 10, 2023)
  • Z-1782-2023 Class I — CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defi (May 10, 2023)
  • Z-1771-2023 Class I — CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter (May 10, 2023)
  • Z-1812-2023 Class I — ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardio (May 10, 2023)
  • Z-1804-2023 Class I — ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardiover (May 10, 2023)
  • Z-1735-2023 Class I — CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardiover (May 10, 2023)
  • Z-1760-2023 Class I — CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardiov (May 10, 2023)
  • Z-1766-2023 Class I — CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter (May 10, 2023)
  • Z-1724-2023 Class I — ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Card (May 10, 2023)
  • Z-1718-2023 Class I — ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibr (May 10, 2023)

FDA data resources