Heart Sync, Inc Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
Brand
Heart Sync, Inc
Lot Codes / Batch Numbers
Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
Products Sold
Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.
Heart Sync, Inc is recalling Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in due to The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
Recommended Action
Per FDA guidance
The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026