Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
This recall has been terminated (originally issued June 27, 2013).
- Recall Initiated
- June 7, 2013
- Posted
- June 27, 2013
- Terminated
- March 7, 2014
- Recall Number
- Z-1607-2013
- Quantity
- 1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic recently identified an issue with a subset of Consulta CRT-P and Syncra CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi
Distribution
Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom, Uruguay , and Yemen. UPDATED Physicians location in USA: AL, AR, FL, GA, IL, IN, KS. LA, ME, MI, MN, MO, NY, OH, PA, SC, TN, TX and VA. OUS: Luxembourg
Lot / Code Info
UPDATED 7/18/2013: Serial Numbers: PVX610233S, PVX610234S, PVX610253S, PVX610258S, PVX610296S, PVX610302S, PVX610308S, PVX610311S, PVX610312S, PVX610313S, PVX610314S, PVX610315S, PVX610317S, PVX610318S, PVX610319S, PVX610320S, PVX610321S, PVX610323S, PVX610324S, PVX610325S, PVX610326S, PVX610328S, PVX610329S, PVX610331S, PVX610332S, PVX610334S, PVX610335S, PVX610337S, PVX610338S, PVX610339S, PVX610340S, PVX610341S, PVX610342S, PVX610343S, PVX610344S, PVX610346S, PVX610347S, PVX610348S, PVX610350S, PVX610352S, PVX610353S, PVX610355S, PVX610358S, PVX610360S, PVX610361S, PVX610364S, PVX610366S, PVX610367S, PVX610368S, PVX610371S, PVX610372S, PVX610373S, PVX610374S, PVX610375S, PVX610376S, PVX610377S, PVX610378S, PVX610379S, PVX610380S, PVX610381S, PVX610382S, PVX610383S, PVX610384S, PVX610385S, PVX610386S, PVX610387S, PVX610388S, PVX610389S, PVX610390S, PVX610391S, PVX610392S, PVX610393S, PVX610395S, PVX610396S, PVX610397S, PVX610398S, PVX610399S, PVX610400S, PVX610401S, PVX610403S, 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PZX626769S, PZX626770S, PZX626776S, PZX626777S, PZX626783S, PZX626786S, PZX626788S, PZX626789S, PZX626790S, PZX626799S, PZX626802S, PZX626803S, PZX626826S, PZX626837S, PZX626842S, PZX626859S, PZX626895S, PZX626907S, PZX626913S, PZX626915S, PZX626916S, PZX626918S, PZX626928S, PZX626933S, PZX626934S, PZX626949S, PZX626950S, PZX626953S, PZX626954S, PZX626958S, PZX626960S, PZX626964S, PZX626966S, PZX626967S, PZX626970S, PZX626982S, PZX626984S, PZX626986S, PZX626988S, PZX626990S, PZX626993S, PZX626994S, PZX626996S, PZX626997S, PZX626998S, PZX627010S, PZX627012S, PZX627013S, PZX627016S, PZX627021S, PZX627022S, PZX627024S.
Root Cause
Nonconforming Material/Component
Action Taken
Medtronic sent an Urgent Medical Device Recall letter dated June 7, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately return non-implanted devices to Medtronic and to register the implanted ones immediately by calling the Medtronic Patient Registration Department at 1-800-848-9300. Customers with questions were instructed to contact their local Medtronic representative or Medtronic Customer Service at 1-800-848-9300. For questions regarding this recall call 763-526-6000. UPDATE: An Urgent Medical Device Correction letter, dated June 2013, was sent to affected implanting and following physicians beginning June 28, 2013. In the US these letters were hand delivered by a Medtronic representative. Outside the US, the notice will be mailed or hand delivered as determined by the geographic center. The letter informed physicians that they have implanted or are following a patient implanted with a device potentially affected by the connector bracket weld issue. The letter described how a loss of hermeticity may affect the device functionality and what symptoms a patient may experience. The letter also offers patient management recommendations.