Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2018
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibr… - a moderate-severity action.
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibr… was recalled by Boston Scientific Corporation in November 28, 2018. Reason: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery…. Check the official notice for the remedy. Verify recall #Z-0474-2019 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery….
- Moderate
- severity level
- 13K units
- affected scope
- Class II
- classification
- November 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0474-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0474-2019) was formally reported on November 28, 2018, with the manufacturer initiating the action on November 1, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Boston Scientific Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 12,900.
The documented reason for this recall is: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions. Distribution data in the federal record shows the product reached: US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, M…. 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
12,900
Related Recalls
6
0 from same agency
Product description
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Reason for recall
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0474-2019 |
| Date reported | November 28, 2018 |
| Date initiated | November 1, 2018 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Saint Paul, MN |
| Affected scope | 12,900 |
| Distribution | US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Mass… |
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-0474-2019) 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? ▼
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.. Recalled by Boston Scientific Corporation. Units affected: 12,900.
Why was this product recalled? ▼
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2018. Severity: Moderate. Recall number: Z-0474-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0474-2019) 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.
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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 November 28, 2018. 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.