Open, Classified

Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1

FDA Recall Z-1268-2022 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recall StatusOpen, Classified

Product CodeLWS

Date Initiated2022-04-12

Product Quantity3944 units

Reason for Recall

Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Firm Action

A Recall notification was sent to the consignees on 04/12/2022 via the United Parcel Service. The letter instructs the consignee to continue normal follow-up frequency per local clinic protocol and for the consignee to submit the response form.

Root Cause

Software design

Distribution Pattern

Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and internationally to Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Greece, Greenland, Guadeloupe, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kuwait, Liechtenstein, Luxembourg, Malaysia, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, United Arab Emirates, United Kingdom, United States, Uruguay, Australia , Korea, Panama, South Korea

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.