CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report

Lasso NAV eco Reprocessed Diagnostic EP Catheters designed recalled

Stryker Sustainability Solutions is recalling Lasso NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological, distributed in Kansas. The recall was initiated on 23 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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.

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0467-2019
FDA event ID: 81321
Recalling firm: Stryker Sustainability Solutions, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 23 Aug 2018
FDA classified: 14 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Hidden Drug Ingredients
Device type: Heart & Vascular Devices

Timeline

23 Aug 2018	Recall initiated by company
14 Nov 2018	Classified by FDA	+83 days
21 Nov 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.

Where it was distributed

US: KS OUS: None

Kansas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

US: KS OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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