FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
- Recall number
- Z-0467-2019
- 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.
- Status
- Terminated
- Initiated
- 2018-08-23
- Posted
- not on file
- Terminated
- 2021-02-04
- Reason
- 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.
- 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
- 2
- Distribution
- US: KS OUS: None
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K112292"]
- PMA numbers
- not on file
- Product code
- NLH
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28