Z-1950-2011

Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external...

Name: Z-1950-2011 Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external...
Creator: Heart Sync, Inc
Published: 2008-12-05
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2008-12-05 / Terminated / root cause: manufacturing process

FDA source

Heart Sync, Inc began a recall of Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications... on 2008-12-05. The reason FDA records is "The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1950-2011
Status: Terminated
Initiated: 2008-12-05
Posted: 2011-04-12
Terminated: 2011-04-13
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
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.
Product code: MLN Electrode, Electrocardiograph, Multi-Function
Reason for recall: The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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.
Quantity in commerce: 2100 (210 cases of 10 each)
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: Y091008-13, Y091008-14, Y111208-13, and Y111208-14.

Product code MLN

K080421Class IIIHeart Sync, Models C-100 and T-100Heart Sync, LLC / cleared 2008-02-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)