Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 20, 2019
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DD… - a critical-severity action.
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DD… was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) in February 20, 2019. Reason: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019…. Check the official notice for the remedy. Verify recall #Z-0811-2019 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) issued this critical-severity FDA Devices recall-A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- February 20, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0811-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0811-2019) was formally reported on February 20, 2019, with the manufacturer initiating the action on January 17, 2019. 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 2040 units.
The documented reason for this recall is: A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, m… Distribution data in the federal record shows the product reached: Wordlwide. 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 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
2040 units
Related Recalls
6
0 from same agency
Product description
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Reason for recall
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0811-2019 |
| Date reported | February 20, 2019 |
| Date initiated | January 17, 2019 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Firm location | Mounds View, MN |
| Affected scope | 2040 units |
| Distribution | Wordlwide |
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-0811-2019) 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.
- 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? ▼
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 2040 units.
Why was this product recalled? ▼
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2019. Severity: Critical. Recall number: Z-0811-2019.
Where was the recalled product distributed? ▼
Distribution: Wordlwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0811-2019) 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 20, 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.