FDA Medical Device Recalls (openFDA)
ev3, Inc.: ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Recall number
- Z-1552-2016
- Recalling firm
- ev3, Inc.
- Product
- ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Status
- Terminated
- Initiated
- 2016-03-29
- Posted
- 2016-04-22
- Terminated
- 2017-05-19
- Reason
- Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
- Root cause
- Labeling False and Misleading
- Action
- Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.
- Quantity
- 27 (25 US, 2 OUS)
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Lot, serial or model codes
- A213373 and A216702
- 510(k) numbers
- ["K093286"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3008114455
- Firm city
- Minneapolis
- Firm state
- MN
- 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