OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Summary
The FDA issued a Class II for OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini a by IMPULSE DYNAMICS (USA) INC. Reason: OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart fai.
Details
Source
Device Recall
External ID
Z-1173-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
Lot/Code Info: OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.
Quantity Affected: 1,469 total units
Reason for Recall
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
Distribution
Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-05
Company
Marlton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IMPULSE DYNAMICS (USA) INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IMPULSE DYNAMICS (USA) INC have FDA actions?
This is the only FDA action we have on record for IMPULSE DYNAMICS (USA) INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1173-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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