Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 31, 2017
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure recalled Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D Sur… - a moderate-severity action.
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D Sur… was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure in May 31, 2017. Reason: An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Am…. Check the official notice for the remedy. Verify recall #Z-2117-2017 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure issued this moderate-severity FDA Devices recall-An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Am….
- Moderate
- severity level
- Class II
- classification
- May 31, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2117-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2117-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on April 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc., Cardiac Rhythm and Heart Failure is listed as the recalling firm, operating out of Mounds View, MN. Federal records list the affected scope as 25,025 ( 16,369 US; 8,656 OUS).
The documented reason for this recall is: An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices. Distribution data in the federal record shows the product reached: USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam…. 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
25,025 ( 16,369 US; 8,656 OUS)
Related Recalls
6
3 from same agency
Product description
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Reason for recall
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2117-2017 |
| Date reported | May 31, 2017 |
| Date initiated | April 12, 2017 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Firm location | Mounds View, MN |
| Affected scope | 25,025 ( 16,369 US; 8,656 OUS) |
| Distribution | USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman … |
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-2117-2017) 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? ▼
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure. Units affected: 25,025 ( 16,369 US; 8,656 OUS).
Why was this product recalled? ▼
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2117-2017.
Where was the recalled product distributed? ▼
Distribution: USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2117-2017) 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 May 31, 2017. 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.