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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
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