FDA Devices recall · Reported July 3, 2013
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed d…
Medtronic Inc. Cardiac Rhythm Disease Management recalled Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT… - a moderate-severity action.
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT… was recalled by Medtronic Inc. Cardiac Rhythm Disease Management in July 3, 2013. Reason: Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during prod…. Check the official notice for the remedy. Verify recall #Z-1607-2013 with the FDA Devices before acting.
The recall
Medtronic Inc. Cardiac Rhythm Disease Management issued this moderate-severity FDA Devices recall-Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during prod….
- Moderate
- severity level
- Class II
- classification
- July 3, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1607-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Reason for recall
Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1607-2013 |
| Date reported | July 3, 2013 |
| Date initiated | June 7, 2013 |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Firm location | Saint Paul, MN |
| Affected scope | 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected |
| Distribution | Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland… |
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-1607-2013) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026