CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00763000178253, Serial Number: RTS605244S; GTIN: 00763000178277, Serial Numbers: RTS604876S, RTS604877S, RTS604879S, RTS604885S; GTIN: 00763000711245, Serial Numbers: RTS604695S, RTS604698S, RTS604700S, RTS604703S, RTS604704S, RTS604714S, RTS604716S, RTS604717S, RTS604718S, RTS604721S, RTS604722S, RTS604723S, RTS604724S, RTS604726S, RTS604727S, RTS604728S, RTS604729S, RTS604730S, RTS604731S, RTS604732S, RTS604733S.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc.
- Reason for Recall:
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Product Codes/Lot Numbers:
GTIN: 00763000178253, Serial Number: RTS605244S; GTIN: 00763000178277, Serial Numbers: RTS604876S, RTS604877S, RTS604879S, RTS604885S; GTIN: 00763000711245, Serial Numbers: RTS604695S, RTS604698S, RTS604700S, RTS604703S, RTS604704S, RTS604714S, RTS604716S, RTS604717S, RTS604718S, RTS604721S, RTS604722S, RTS604723S, RTS604724S, RTS604726S, RTS604727S, RTS604728S, RTS604729S, RTS604730S, RTS604731S, RTS604732S, RTS604733S.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2195-2024
Related Recalls
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
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.