PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to b...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0035-2018.
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0035-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact St Jude Medical Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0035-2018.
St Jude Medical Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
St Jude Medical Inc. Recall FAQ
St Jude Medical Inc. is the subject of a medical implants safety report: PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to b.... The notice was published on August 28, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 101 units are potentially affected.