Recall Z-1268-2022 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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
| Date | Apr 12, 2022 |
| Status | Open, Classified |
| Reason | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). |
| Root cause | Software design |
| 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. |
| Quantity | 3944 units |
| Distribution | 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 Daru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.