Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 13, 2019
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices - a moderate-severity action.
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) in February 13, 2019. Reason: The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use …. Check the official notice for the remedy. Verify recall #Z-0796-2019 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) issued this moderate-severity FDA Devices recall-The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use ….
- Moderate
- severity level
- 33K units
- affected scope
- Class II
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0796-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0796-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on January 17, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. 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 33007 units.
The documented reason for this recall is: The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer R… Distribution data in the federal record shows the product reached: US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic. 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 - 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 - 40,422 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
33007 units
Related Recalls
6
0 from same agency
Product description
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Reason for recall
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0796-2019 |
| Date reported | February 13, 2019 |
| Date initiated | January 17, 2019 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Firm location | Mounds View, MN |
| Affected scope | 33007 units |
| Distribution | US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic |
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-0796-2019) 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? ▼
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 33007 units.
Why was this product recalled? ▼
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Moderate. Recall number: Z-0796-2019.
Where was the recalled product distributed? ▼
Distribution: US, Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0796-2019) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 February 13, 2019. 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.