Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 23, 2025
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Abbott Medical recalled Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0541506704… - a moderate-severity action.
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 0541506704… was recalled by Abbott Medical in April 23, 2025. Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures wh…. Check the official notice for the remedy. Verify recall #Z-1557-2025 with the FDA Devices before acting.
The recall
Abbott Medical issued this moderate-severity FDA Devices recall-Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures wh….
- Moderate
- severity level
- 6 units
- affected scope
- Class II
- classification
- April 23, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1557-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1557-2025) was formally reported on April 23, 2025, with the manufacturer initiating the action on February 15, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Medical is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 6 devices.
The documented reason for this recall is: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted…. 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, 3 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 - 40,322 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
6 devices
Related Recalls
6
3 from same agency
Product description
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Reason for recall
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1557-2025 |
| Date reported | April 23, 2025 |
| Date initiated | February 15, 2025 |
| Recalling firm | Abbott Medical |
| Firm location | Sylmar, CA |
| Affected scope | 6 devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two … |
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-1557-2025) 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? ▼
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.. Recalled by Abbott Medical. Units affected: 6 devices.
Why was this product recalled? ▼
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Moderate. Recall number: Z-1557-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and the country of Spain. There were five (5) LSP202V devices distributed within the United States (3 in FL, 1 in SC, 1 in WV) that are impacted by this issue, two (2) of which were implanted, see Attachment A.3 for list of serial numbers. There is 1 LSP112V device that is impacted by this issue, but this was distributed outside of the United States. See Attachment A.4 for list of OUS serial numbers..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1557-2025) 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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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 April 23, 2025. 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.