Heart Sync Adult Radiolucent Electrode -Physio Control… recallZ-1951-2011 · Heart Sync, Inc · initiated Dec 5, 2008
Terminated All recalls posted in April 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Heart Sync, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
FDA root cause category: Equipment maintenance
What the company is doing
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.
Recall details
- Recall number
- Z-1951-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 5, 2008
- Posted by the FDA
- Apr 12, 2011
- Recalling firm
- Heart Sync, Inc
- Quantity
- 50 (5 cases of 10 each)
- Product code
- MLN
- FDA submissions
- K080421
- Distribution
- Nationwide Distribution
Product description
Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
Code information (models, lots, serial numbers)
Lot Number: Y111208-6.
Other devices under the same FDA submission
4 devices cleared under K080421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Curaplex 16384Bound Tree Medical, LLC · Electrode, electrodcardiograph, multi-function4 reports
- Curaplex 16242Bound Tree Medical, LLC · Electrode, electrodcardiograph, multi-function1 report
- Curaplex 16250Bound Tree Medical, LLC · Electrode, electrodcardiograph, multi-function1 report
- Curaplex 16381Bound Tree Medical, LLC · Electrode, electrodcardiograph, multi-function1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 57815).
- Z-1950-2011 · TerminatedMedstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, di…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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