Medtronic Recalls Two Defective Implantable Cardioverter Defibrillators
Medtronic is recalling two Cobalt HF Quad MRI SureScan CRT-D devices due to a potential missing resistance spot weld.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a high-risk medical device (ICD) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Inc. is recalling two units of the Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D). The recall is limited to specific units identified by Product Number DTPB2D4 and Serial Numbers RTO601595S and RTO601624S.
The recall is being issued because the devices may contain a manufacturing defect involving a missing resistance spot weld (RSW). These devices are multiprogrammable cardiac devices used to monitor and regulate heart rate by providing bradycardia pacing, cardioversion, and defibrillation therapies.
The affected units were distributed in North Carolina. Patients with these specific devices should contact their healthcare provider or Medtronic for further instructions regarding the defect.
The recalled product
- Product
- 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…
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Number: DTPB2D4
- UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Distribution
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