Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
Medtronic is recalling 14 units of CRTD VIVA QUAD XT implantable cardioverter defibrillators due to rare potential for reduced or no energy output during high voltage therapy. Affected devices were manufactured with a specific feedthrough defect.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires minimum severity of 4 (Severe). The defect affects a life-critical implantable cardiac device where failure to deliver therapy could have serious health consequences, though no illnesses or injuries have been reported in the source material.
Plain-English summary
Medtronic Inc. is recalling 14 units of the CRTD VIVA QUAD XT CUST PARY GOLD implantable cardioverter defibrillators (Model DTBA1QQPG). These are life-sustaining devices implanted in cardiac patients to regulate abnormal heart rhythms and deliver therapy when needed.
The recall is due to a rare potential for reduced or no energy output during high voltage (HV) therapy (typically 0-12 joules) in devices manufactured with a specific glassed feedthrough. This defect could impair the device's ability to deliver therapy when required.
The affected devices have US nationwide and worldwide distribution. Affected lot serial numbers are: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, and BLC229010H.
The recalled product
- Product
- CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators
- Affected units
- 14
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 (15)
- GTIN 00643169968585
- Lot Serial Numbers: BLC229283H
- BLC229226H
- BLC229270H
- BLC229280H
- BLC229229H
- BLC228997H
- BLC229238H
- BLC229043H
- BLC229231H
- BLC229046H
- BLC229045H
- BLC229230H
- BLC228995H
- BLC229010H
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12