Device recall: Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D…
Class II FDA enforcement event 75943. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.
Class II, in the words of FDA
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
Medtronic Inc., Cardiac Rhythm and Heart Failure started this device recall on 9 Dec 2016. The firm address in the FDA record is in Mounds View, MN. FDA put the recall in Class II. FDA event 75943 has 1 product record. The first FDA enforcement report date is 18 Jan 2017. The record gives the status Terminated, with the termination date 16 Jul 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia,…
Recalling firm
Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0962-2017 | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. | 21,111 ( 13,198 US; 7,913 OUS). | Class II | Terminated | 18 Jan 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jul 2017 | MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The mon | Device | Class II | 2 |
| 12 Apr 2017 | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan | Device | Class II | 1 |
| 12 Aug 2016 | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT | Device | Class II | 2 |
| 16 Jun 2016 | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416 | Device | Class II | 1 |
| 26 May 2016 | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring | Device | Class II | 1 |
| 31 Mar 2016 | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Ho | Device | Class II | 1 |
Medtronic Inc., Cardiac Rhythm and Heart Failure: all 7 events
Official channels
- FDA enforcement report Z-0962-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 75943. https://recallregister.com/fda/ii/75943/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia,…
- What quantity of product is in FDA event 75943?
- The FDA record gives this quantity:
21,111 ( 13,198 US; 7,913 OUS).
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.