FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
- Recall number
- Z-2365-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
- Status
- Terminated
- Initiated
- 2008-06-19
- Posted
- 2008-09-21
- Terminated
- 2010-10-13
- Reason
- Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of the PTFE coating to detach from the wi
- Root cause
- Process control
- Action
- An urgent Voluntary medical Device Recall or Correction - Immediate Action Required letter was sent to all affected customers. The letter describes the issue and clinical effects. A list of affected devices is attached to the letter. The customer is to cease use or distribution of affected product, and return it immediately to Boston Scientific. Return directions are provided in an attached document. A Reply Verification Tracking Form is to be completed and faxed back to Customer Service. If any product is being returned the completed form is to accompany the returned product. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.
- Quantity
- 22,397 single units total (18,261 US, 4,136 OUS)
- Distribution
- AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
- Lot, serial or model codes
- Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696, 8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162, 8432959, 8506417, 8533771, and 11643756.
- 510(k) numbers
- ["K935997"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- 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