Z-1137-2017Class II

Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a)...

Name: Z-1137-2017 Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a)...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2016-09-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-09-07 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No... on 2016-09-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1137-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2017-02-03
Terminated: 2017-04-06
Recalling firm: Boston Scientific Corporation
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.
Product code: LJW Tracheotome
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 9/7/2016, AngioDynamics, Inc. sent URGENT VOLUNTARY MEDICAL DEVICE RECALL Notifications (dated 9/7/2016) to 47 consignees via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics and complete and return the Reply Verification Tracking Form, provided in the recall notification. Please call AngioDynamics Customer Service at 1-800-772-6446 Monday - Friday between 8:00 am and 7:00 Pm EST to obtain a replacement or credit for returned product.
Distribution: AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
Product codes and lots: AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D; medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1137-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1137-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-03

Product code LJW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)