Z-0467-2019Class II

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain...

Name: Z-0467-2019 Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain...
Creator: Stryker Sustainability Solutions
Published: 2018-08-23
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2018-08-23 / Terminated

FDA source

Stryker Sustainability Solutions began a recall of Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of... on 2018-08-23. FDA classified it as Class II and gives the reason as "Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0467-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-23
Posted: 2018-11-14
Terminated: 2021-02-04
Recalling firm: Stryker Sustainability Solutions
Product: Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
FDA root cause: Under Investigation by firm
Action: On 10/30/2018 an Urgent Medical Device Recall notice was hand-delivered by a sales representative to the customer. The customer was notified that the affected devices had already been returned via the normal collections process. If affected devices were forwarded to additional facilities, the customer was asked to communicate this recall to them and to provide them with the recall effectiveness check form. Customers were asked to complete and return the recall effectiveness check form.
Quantity in commerce: 2
Distribution: US: KS OUS: None
Product codes and lots: Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-14

Product code NLH

K112292Class IIReprocessed 2515 Nav Variable Electrophysiology CatheterStryker Sustainability Solutions / cleared 2011-10-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)