Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 14, 2021
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Heart Valves Division recalled CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US; - a moderate-severity action.
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US; was recalled by Medtronic Heart Valves Division in July 14, 2021. Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufact…. Check the official notice for the remedy. Verify recall #Z-2043-2021 with the FDA Devices before acting.
The recall
Medtronic Heart Valves Division issued this moderate-severity FDA Devices recall-Due to reports of actuator separation for various delivery catheter systems. Affected products were manufact….
- Moderate
- severity level
- Class II
- classification
- July 14, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2043-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2043-2021) was formally reported on July 14, 2021, with the manufacturer initiating the action on June 11, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Heart Valves Division is listed as the recalling firm, operating out of Santa Ana, CA. Federal records list the affected scope as Total of all Delivery Systems (Globally) = 67,339 units.
The documented reason for this recall is: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. Distribution data in the federal record shows the product reached: U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S…. 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, 6 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 - 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
Total of all Delivery Systems (Globally) = 67,339 units
Related Recalls
6
6 from same agency
Product description
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Reason for recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2043-2021 |
| Date reported | July 14, 2021 |
| Date initiated | June 11, 2021 |
| Recalling firm | Medtronic Heart Valves Division |
| Firm location | Santa Ana, CA |
| Affected scope | Total of all Delivery Systems (Globally) = 67,339 units |
| Distribution | U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentin… |
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-2043-2021) 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? ▼
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;. Recalled by Medtronic Heart Valves Division. Units affected: Total of all Delivery Systems (Globally) = 67,339 units.
Why was this product recalled? ▼
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2043-2021.
Where was the recalled product distributed? ▼
Distribution: U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2043-2021) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 14, 2021.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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 June 2026.