High RiskFDAfda-Z-0023-2018BATTERY HAZARD

Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

Q: What is being recalled?

St. Jude Medical, Inc. is the subject of a medical implants safety report: Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663. The notice was published on September 12, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 3,119 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a battery hazard concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this product?

Stop using the product. Check the lot number, model number, or sell-by date against the recall notice above. Then contact St. Jude Medical, Inc. or the retailer where you purchased it to request a refund, replacement, or repair. The official FDA page has the most current instructions: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is a refund or replacement free?

Yes. Under federal recall procedures, consumers are entitled to a remedy at no cost — typically a full refund, free replacement, or free repair. There is generally no expiration on safety recalls. Keep your receipt if possible, but most agencies require remedies even without proof of purchase.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information.

Q: Is this an FDA food or cosmetic recall?

This recall is in the FDA's jurisdiction and may cover food, dietary supplements, cosmetics, or related products. Follow the FDA's official guidance in the notice above. If you have consumed the product and are concerned about your health, contact a healthcare provider.

Brand

St. Jude Medical, Inc.

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0023-2018.

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0023-2018.

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-0023-2018.

St. Jude Medical, Inc.

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

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.

How to report to FDA →File a report at FDA →

St. Jude Medical, Inc. Recall FAQ

What is being recalled?

St. Jude Medical, Inc. is the subject of a medical implants safety report: Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663. The notice was published on September 12, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 3,119 units are potentially affected.

Why was this product recalled?

What should I do if I have this product?

Is a refund or replacement free?

Has anyone been hurt by this product?

Where can I get more information?

Is this an FDA food or cosmetic recall?

Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

FDA Recall Notice

Corrective Action (per FDA)

✅ What you should do

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report a food, supplement, or cosmetic problem to the FDA

St. Jude Medical, Inc. Recall FAQ

Other recalls from St. Jude Medical, Inc.

Other medical implants recalls