Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.
This recall has been terminated (originally issued April 8, 2009).
- Recall Initiated
- November 3, 2008
- Posted
- April 8, 2009
- Terminated
- May 10, 2012
- Recall Number
- Z-1172-2009
- Quantity
- 55,755
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
Distribution
Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.
Lot / Code Info
v1.0 software
Root Cause
Software design
Action Taken
Between November 24 and December 9, 2008 US CRDM are responsible to hand deliver the consignee letter, a Medtronic "Urgent Patient Management Information," dated November 2008, to impacted physicians to make them aware of the issue and continue to promote and install LIA (by using the new LIA tipcard). For any physician listed that a confirmation sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The letter also gave recommendations and informed consignees in regard to a future update to the LIA software for EnTrust devices.