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Anthem CRT-P models PM3110 and PM3210 recallZ-0430-2012 · St Jude Medical CRMD · initiated Sep 23, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from St Jude Medical CRMD or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Pending

What the company is doing

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.

Recall details

Recall number
Z-0430-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 23, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
St Jude Medical CRMD
Quantity
14,000 units
Product code
DXY
FDA submissions
P030035, P880086
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.

Product description

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, lots, serial numbers)

Models PM3110, 3112, 3210,3212 (Anthem) and    All lots and serial numbers

Other devices under the same FDA submission

48 devices cleared under P030035, P880086 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60134).

Sources and updates

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