Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Reported: July 31, 2024 Initiated: May 22, 2024 #Z-2432-2024
Product Description
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Reason for Recall
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Details
- Recalling Firm
- Abbott Medical
- Units Affected
- 1198 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA, WI, WY and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom.
- Location
- Plano, TX
Frequently Asked Questions
What product was recalled? ▼
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only. Recalled by Abbott Medical. Units affected: 1198 units.
Why was this product recalled? ▼
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2024. Severity: Moderate. Recall number: Z-2432-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11