Celerity ECG Cable Accessory Pack — Class II medical device recall Z-1137-2017
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2017-02-15, distributed in AZ, CA, FL, GA, IL, IN, KS, MD…. The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly man
| Recall number | Z-1137-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2016-09-07 |
| Classified | 2017-02-03 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-04-06 |
| Distributed | AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI |
| Lot numbers | 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D |
| Model numbers | 47-143, MRLCA000 |
Product
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
Reason for recall
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
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-1137-2017. 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.