Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Medical device recall Z-2117-2017. Published in FDA’s Enforcement Report on May 31, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 31, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 25,025 ( 16,369 US; 8,656 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia’ “’, Claria’”’, and Compia’”’ Quad CRT-D MRI devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
25,025 ( 16,369 US; 8,656 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UPN Lot Serial # 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA200006H 00643169543362 RPA200007H 00643169543362 RPA200008H 00643169543362 RPA200009H 00643169543362 RPA200010H 00643169543362…
Every code shown here, 1,993 characters
UPN Lot Serial # 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA200006H 00643169543362 RPA200007H 00643169543362 RPA200008H 00643169543362 RPA200009H 00643169543362 RPA200010H 00643169543362 RPA200011H 00643169543362 RPA200012H 00643169543362 RPA200013H 00643169543362 RPA200014H 00643169543362 RPA200015H 00643169543362 RPA200016H 00643169543362 RPA200017H 00643169543362 RPA200018H 00643169543362 RPA200019H 00643169543362 RPA200021H 00643169543362 RPA200022H 00643169543362 RPA200023H 00643169543362 RPA200024H 00643169543362 RPA200025H 00643169543362 RPA200026H 00643169543362 RPA200027H 00643169543362 RPA200028H 00643169543362 RPA200029H 00643169543362 RPA200030H 00643169543362 RPA200031H 00643169543362 RPA200032H 00643169543362 RPA200033H 00643169543362 RPA200034H 00643169543362 RPA200035H 00643169543362 RPA200036H 00643169543362 RPA200037H 00643169543362 RPA200038H 00643169543362 RPA200039H 00643169543362 RPA200040H 00643169543362 RPA200041H 00643169543362 RPA200042H 00643169543362 RPA200043H 00643169543362 RPA200044H 00643169543362 RPA200045H 00643169543362 RPA200046H 00643169543362 RPA200047H 00643169543362 RPA200048H 00643169543362 RPA200049H 00643169543362 RPA200050H 00643169543362 RPA200051H 00643169543362 RPA200052H 00643169543362 RPA200053H 00643169543362 RPA200054H 00643169543362 RPA200055H 00643169543362 RPA200056H 00643169543362 RPA200057H 00643169543362 RPA200058H 00643169543362 RPA200059H 00643169543362 RPA200060H 00643169543362 RPA200061H 00643169543362 RPA200062H 00643169543362 RPA200063H 00643169543362 RPA200064H 00643169543362 RPA200065H 00643169543362 RPA200066H 00643169543362 RPA200067H 00643169543362 RPA200068H 00643169543362 RPA200069H 00643169543362 RPA200070H 00643169543362 RPA200071H 00643169543362 RPA200072H 00643169543362 RPA200073H 00643169543362 RPA200074H 00643169543362 RPA200075H 00643169543362 RPA200076H 00643169543362 RPA200077H 00643169543362 RPA200078H 00643169543362 RPA200079H…
FDA’s list runs to 776,311 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
- District of Columbia
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 12, 2017.
- FDA classified it on May 19, 2017.
- FDA’s Enforcement Report published it on May 31, 2017.
- FDA terminated it on Jul 16, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure, of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 776,311 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.