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Recall Observatory FDA recall evidence

Device product

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.

Z-1607-2013

June 07, 2013

Class II

Product summary

Firm
Medtronic Inc. Cardiac Rhythm Disease Management
Event
Event 65433
Status
Terminated
Classification
Class II
Quantity
1912 (159 USA & 1137 OUS) UPDATED: 1128 affected
Official record key
device-enforcement:Z-1607-2013

Official wording

Reason: 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

Code information: 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, 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PZX626768S, 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.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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

Field note

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