Medtronic Inc.: Device Recall

Recall Details

Recall Number

Z-2207-2024

Classification

Class II

Product Type

Device

Recalling Firm

Medtronic Inc.

Status

Ongoing

Date Initiated

04/16/2024

Location

Mounds View, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

36 units

Reason for Recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Product Description

COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Other Recalls by Medtronic Inc.

• Class II: Risk 12/04/2025
  Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
• Class II: Risk 10/29/2025
  There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
• Class II: Risk 06/18/2025
  In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
• Class II: Risk 06/18/2025
  In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
• Class II: Risk 06/17/2025
  A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

View all recalls by Medtronic Inc. →