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U.S. Department of Health and Human Services

Class 2 Device Recall Anthem CRTP

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  Class 2 Device Recall Anthem CRTP see related information
Date Initiated by Firm September 23, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-0430-2012
Recall Event ID 60134
PMA Number P030035 P880086 
Product Classification Implantable pacemaker pulse-generator - Product Code DXY
Product Anthem CRT-P models PM3110 and PM3210

St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Code Information Models PM3110, 3112, 3210,3212 (Anthem) and    All lots and serial numbers
Recalling Firm/
Manufacturer		 St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact
818-362-6822
Manufacturer Reason
for Recall		 St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
FDA Determined
Cause 2		 Pending
Action The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.
Quantity in Commerce 14,000 units
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DXY and Original Applicant = Abbott Medical
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