Z-1986-2016Class II

BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela...

Name: Z-1986-2016 BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela...
Creator: Navilyst Medical, Inc., an AngioDyamics Company
Published: 2016-03-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-03-14 / Terminated / root cause: design

FDA source

Navilyst Medical, Inc., an AngioDyamics Company began a recall of BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo... on 2016-03-14. FDA classified it as Class II and gives the reason as "PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter". 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-1986-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-14
Posted: 2016-06-14
Terminated: 2018-06-11
Recalling firm: Boston Scientific Corporation
Product: BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV 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 and 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: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Root cause tag: design
FDA root cause: Device Design
Action: Navilyst Medical distributed Urgent Voluntary Medical Device Recall notification letters on March 14, 2016, and Reply Tracking forms to their customers via courier service. Customers were asked to immediately remove any affected (recalled) product from their inventory (whether in labs, central supply, shipping and receiving or any other location). Segregate this product in a secure location for return to Navilyst Medical. Immediately forward a copy of the recall notice to all sites to which you have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 Monday to Friday, 8 am - 7 pm, EST to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) by fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.
Quantity in commerce: 10 units
Distribution: Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Product codes and lots: Batch/Lots: 4806370 Use By 2016-10-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1986-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1966-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1967-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1968-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1969-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1970-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1971-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1972-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1973-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1974-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1975-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1976-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1977-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1978-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1979-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1980-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1981-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1982-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1983-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1984-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1985-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1986-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1987-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14
Z-1988-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code LJS

K021704Class IIVaxcel Picc with Pasv Valve TechnologyCatheter Innovations, Inc. / cleared 2002-06-06

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)