Merlin — Class II medical device recall Z-1497-2022

Ongoing recall by St. Jude Medical, Cardiac Rhythm Management Division, reported 2022-08-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program,

Recall number	`Z-1497-2022`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, United States
Recall initiated	2022-06-17
Classified	2022-08-02
Reported by FDA	2022-08-10
Distributed	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY
Countries outside the US	AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA
UPC / GTIN / UDI-DI	`05414734509732`
Model numbers	`MN5000`

Product

Merlin.net model MN5000 Software

Reason for recall

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1497-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.