CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report
Abbott Infinity 7, Implantable Pulse Generator recalled
Abbott Medical is recalling Abbott Infinity 7, Implantable Pulse Generator, distributed nationwide in the US. The recall was initiated on 22 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2431-2024
- FDA event ID
- 94796
- Recalling firm
- Abbott Medical, Plano, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2024
- FDA classified
- 25 Jul 2024
- Reported
- 31 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 May 2024 | Recall initiated by company | |
| 25 Jul 2024 | Classified by FDA | +64 days |
| 31 Jul 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNorth Dakota
Questions about this recall
Why was it 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 lots are affected?
All Serial numbers/UDI: 05415067030023 and 05415067020260
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 94796This product is part of a recall event; the main page for the event is Abbott Infinity 7, Implantable Pulse Generator recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Abbott Infinity 7, Implantable Pulse Generator recalled | Abbott Medical | Other | Nationwide | |
| CLASS II | Abbott Infinity 5, Implantable Pulse Generator recalled | Abbott Medical | Other | Nationwide | |
| CLASS II | Abbott Infinity 5, Implantable Pulse Generator recalled | Abbott Medical | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Merlin" Patient Care System (PCS) recalled by Abbott Medical | Abbott Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Liberta RC DBS IPG (Implantable Pulse Generator) recalled | Abbott Medical | Other | TX |
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| Device | CLASS III | Merlin@home with the MerlinOnDemand capability Transmitter recalled | Abbott Medical | Device Malfunction | Nationwide |
| Device | CLASS III | Merlin@home Transmitter recalled by Abbott Medical | Abbott Medical | Device Malfunction | Nationwide |
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