Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 20, 2013
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Isoline defibrillation leads distributed may have internal insulation breach.
Sorin Group USA, Inc. recalled Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead… - a moderate-severity action.
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead… was recalled by Sorin Group USA, Inc. in March 20, 2013. Reason: Isoline defibrillation leads distributed may have internal insulation breach.. Check the official notice for the remedy. Verify recall #Z-0928-2013 with the FDA Devices before acting.
The recall
Sorin Group USA, Inc. issued this moderate-severity FDA Devices recall-Isoline defibrillation leads distributed may have internal insulation breach..
- Moderate
- severity level
- Class II
- classification
- March 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0928-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0928-2013) was formally reported on March 20, 2013, with the manufacturer initiating the action on January 28, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Sorin Group USA, Inc. is listed as the recalling firm, operating out of Arvada, CO. Federal records list the affected scope as 1376 Isoline leads.
The documented reason for this recall is: Isoline defibrillation leads distributed may have internal insulation breach. Distribution data in the federal record shows the product reached: Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1376 Isoline leads
Related Recalls
6
3 from same agency
Product description
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Reason for recall
Isoline defibrillation leads distributed may have internal insulation breach.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0928-2013 |
| Date reported | March 20, 2013 |
| Date initiated | January 28, 2013 |
| Recalling firm | Sorin Group USA, Inc. |
| Firm location | Arvada, CO |
| Affected scope | 1376 Isoline leads |
| Distribution | Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwai… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0928-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. Recalled by Sorin Group USA, Inc.. Units affected: 1376 Isoline leads.
Why was this product recalled? ▼
Isoline defibrillation leads distributed may have internal insulation breach.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0928-2013.
Where was the recalled product distributed? ▼
Distribution: Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0928-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.