Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 7, 2021
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillat
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval followi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT… - a critical-severity action.
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT… was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) in April 7, 2021. Reason: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recom…. Check the official notice for the remedy. Verify recall #Z-1306-2021 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) issued this critical-severity FDA Devices recall-A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recom….
- Critical
- severity level
- 238K units
- affected scope
- Class I
- classification
- April 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1306-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1306-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on February 3, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is listed as the recalling firm, operating out of Mounds View, MN. Federal records list the affected scope as 238393 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observat… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
238393 units
Related Recalls
6
3 from same agency
Product description
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Reason for recall
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1306-2021 |
| Date reported | April 7, 2021 |
| Date initiated | February 3, 2021 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Firm location | Mounds View, MN |
| Affected scope | 238393 units |
| Distribution | Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Dar… |
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-1306-2021) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 238393 units.
Why was this product recalled? ▼
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Critical. Recall number: Z-1306-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Montenegro, Morocco, Namibia, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam Virgin Islands (British), Yemen and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1306-2021) 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 April 7, 2021. 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.