FDA Medical Device Recalls (openFDA)
Spectranetics Corporation: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
- Recall number
- Z-0576-2020
- Recalling firm
- Spectranetics Corporation
- Product
- Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
- Status
- Terminated
- Initiated
- 2018-12-07
- Posted
- not on file
- Terminated
- 2020-10-27
- Reason
- The incorrect outer carton box was used for the product.
- Root cause
- Process control
- Action
- The recalling firm issued an undated Dear Healthcare Professional letter via FedEx informing the consignee of the issue, the risk to health, and the actions to be taken. Return of the device was requested.
- Quantity
- 3 catheters
- Distribution
- Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
- Lot, serial or model codes
- AngioSculpt PTCA lot #G18090030.
- 510(k) numbers
- not on file
- PMA numbers
- ["P050018"]
- Product code
- NWX
- Firm FEI
- 3005462046
- Firm city
- Fremont
- Firm state
- CA
- 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