Z-0240-2018Class II

Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN...

Name: Z-0240-2018 Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2016-11-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-11-28 / Terminated / root cause: design

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV... on 2016-11-28. FDA classified it as Class II and gives the reason as "Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0240-2018
Classification: Class II
Status: Terminated
Initiated: 2016-11-28
Posted: 2017-12-14
Terminated: 2019-06-12
Recalling firm: Boston Scientific Corporation
Product: Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to 1. IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics Company) o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. o If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. o Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. o Email Reply Verification Tracking Form (preferred): [email protected] o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product to: AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator. If you have any questions, please call: 518-795-1358 or 518-795-1116.
Quantity in commerce: 4591 units in total
Distribution: Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.
Product codes and lots: Lot 4908974

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0240-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0240-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0241-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0242-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0243-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0244-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0245-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0246-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0247-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0248-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0249-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0250-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0251-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13
Z-0252-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13

Product code LJS

K091261Class IINmi PiccNavilyst Medical, Inc. / cleared 2009-05-12

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)