Medtronic Implantable Cardioverter Defibrillator Model DTPA2D1G Therapy Output Failure
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator due to a rare potential for reduced or no energy output during high-voltage defibrillation therapy.
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: This device is subject to an FDA Class I recall; however, no deaths or serious injuries have been reported and the hazard is described as a rare potential for device failure, preventing a Critical classification.
Plain-English summary
Medtronic Inc. is recalling five units of the CRTD DTPA2D1G COBALT XT HF QUAD OUS implantable cardioverter defibrillator (model DTPA2D1G). The devices are affected by a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range.
The affected devices contain a specific glassed feedthrough component that may cause this malfunction. The recalled units have the following lot serial numbers: RTH602452S, RTH602446S, RTH602443S, RTH602454S, and RTH602442S. These devices were distributed nationwide in the United States and worldwide.
The recalled product
- Product
- CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators
- Affected units
- 5
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 (6)
- GTIN 00763000501044
- lot serial Numbers: RTH602452S
- RTH602446S
- RTH602443S
- RTH602454S
- RTH602442S
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 →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12