# FDA recall Z-1268-2022

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2022-04-12.

## Product

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

## Reason for recall

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

## 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 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

## Key facts

- **Recall number:** Z-1268-2022
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-12
- **Report date:** 2022-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2022

## Citation

> AI Analytics. FDA recall Z-1268-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1268-2022. Source: US FDA. Licensed CC0.

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