Crtd Dtpa2d1g Cobalt XT HF Quad OUS recall
CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
Why was Crtd Dtpa2d1g Cobalt XT HF Quad OUS 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00763000501044, lot serial Numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, RTH602442S
- Product
- CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 5 units
- Distribution
- US Nationwide - Worldwide Distribution
- Recall date
- June 28, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)