Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 25, 2017
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
St Jude Medical Inc. recalled PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices a… - a moderate-severity action.
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices a… was recalled by St Jude Medical Inc. in October 25, 2017. Reason: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers th…. Check the official notice for the remedy. Verify recall #Z-0036-2018 with the FDA Devices before acting.
The recall
St Jude Medical Inc. issued this moderate-severity FDA Devices recall-New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers th….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- October 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0036-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0036-2018) was formally reported on October 25, 2017, with the manufacturer initiating the action on August 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. St Jude Medical Inc. is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 4828 units.
The documented reason for this recall is: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications. Distribution data in the federal record shows the product reached: Worldwide Distribution. 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
4828 units
Related Recalls
6
0 from same agency
Product description
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Reason for recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0036-2018 |
| Date reported | October 25, 2017 |
| Date initiated | August 28, 2017 |
| Recalling firm | St Jude Medical Inc. |
| Firm location | Sylmar, CA |
| Affected scope | 4828 units |
| Distribution | Worldwide Distribution |
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-0036-2018) 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? ▼
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.. Recalled by St Jude Medical Inc.. Units affected: 4828 units.
Why was this product recalled? ▼
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0036-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0036-2018) 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 October 25, 2017. 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.