Heart Sync Recalls Radiotransparent Defibrillation Electrodes Due to Equipment Damage
Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes because a supplier defect may prevent the device from delivering appropriate electrical shocks to patients.
What this means for you
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 medical device where a defect could render it incapable of delivering life-saving shocks, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Heart Sync, Inc. is recalling Vermed Radiotransparent Defibrillation Electrodes, which are used in connection with a defibrillator to deliver electrical current to a patient's heart during cardiac emergencies. The recall involves 17,180 units of Part Number D304 with specific lot numbers.
The recall was initiated after Heart Sync became aware of a recall from a wire/connector sub-assembly supplier. Reports indicated that equipment damage occurred due to misalignment from tooling installed in August 2012. This damage could render the device incapable of delivering the appropriate energy or shock to the patient.
The affected products were distributed worldwide, including in the United States and internationally to Korea. No specific instructions for consumers are provided in the source text beyond the identification of the affected units.
The recalled product
- Product
- Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emerg
- Manufacturer
- Heart Sync, Inc
- Affected units
- 17,180
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)
- Part Number: D304 and lot numbers:Y100112-02
- Y102212-03
- Y121312-18
- Y012413-02
- Y022013-01
- Y032113-01
Distribution
Part of a larger recall action
This product is one of 2 recalled by Heart Sync, Inc 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 2 products in this recall →Related recalls
Same manufacturer · Heart Sync, Inc
See all →- HighHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- SevereHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- HighHeart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- HighHeart Sync Electrodes Recalled for Incompatibility with Philips AEDs
FDA (Devices) · 2014-12-31
- HighHeart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility
FDA (Devices) · 2014-12-31
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
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12